Cardiology News

Despite the extensive recent focus on its cost, insulin use in the United States remains dominated by insulin glargine and other analogs, as well as pen devices for delivery, new research shows.

The findings come from a nationally representative audit of outpatient care with input from nearly 5,000 physicians who prescribed insulin to patients with type 2 diabetes in 2016-2020.

The dramatic rise in the price of insulin in the United States has been extensively discussed in recent years, particularly with the newer analogs as compared with older human insulins.

Few studies indicate analog insulins better than human insulins

“Our findings suggest that even with increased public scrutiny for insulin products ... [the market is] dominated by the use of insulin analogs and insulin pen delivery devices, with persistent uptake of newer products as they are approved,” lead author Rita R. Kalyani, MD, told this news organization.

“Though newer insulins offer potentially greater flexibility with reduced hypoglycemia for many patients, they are also much more costly, with minimal to no head-to-head studies suggesting significant differences in glucose-lowering efficacy when compared to human insulins,” she stressed.

“We found it surprising that, despite the much-publicized concerns regarding insulin costs, analog insulins continue to represent more than 80% of insulin visits in the U.S.” added Dr. Kalyani, of the Division of Endocrinology, Diabetes & Metabolism at Johns Hopkins University School of Medicine, Baltimore.

However, as expected, the study also revealed a gradual increased uptake in the use of biosimilar insulins as more have been introduced to the market.

Dr. Kalyani advised, “Clinicians should be aware of their individual prescribing patterns for insulin and consider the affordability of insulin for patients as part of shared decision-making during clinic visits, particularly given the greater financial strain that many patients have faced during the ongoing COVID-19 pandemic and the rising societal costs for diabetes care.”

The research was published online October 12 in JAMA Network Open by Dr. Kalyani and colleagues.

Analogs prevailed, while biosimilar use rose

The data come from the Health National Disease and Therapeutic Index, a quarterly sampling of approximately 4,800 physicians that provides nationally representative diagnostic and prescribing information on patients treated by office-based physicians in the United States.

Overall, there were 27,860,691 insulin treatment visits for type 2 diabetes in 2016-2020. Of those, long-acting analog insulins (glargine [Lantus], detemir [Levemir], and degludec [Tresiba]) accounted for 67.3% of treatment visits in 2016 and 74.8% of treatment visits in 2020.

Rapid-acting insulin analogs (lispro [Humalog], aspart [Novolog], faster aspart [Fiasp], and glulisine [Apidra]) accounted for about 21.2% of visits in 2016 and about 16.5% in 2020.

On the other hand, intermediate- and short-acting human insulins (NPH and regular) accounted for just 3.7% of visits in 2016 and 2.6% in 2020.

Grouped together, the long- and short-acting analogs accounted for 92.7% of visits in 2016 and 86.3% in 2020, while the human insulins represented just 7.3% of visits in 2016 and 5.5% in 2020.

The biosimilar analog insulins (glargine and lispro) first appeared in the database in 2017, accounting for 2.6% of visits that year and 8.2% by 2020.

Overall, the number of visits for insulin treatment declined by 18% between 2016 and 2020, from 6.0 million to 4.9 million. That drop may be due to multiple factors, Dr. Kalyani said.

“Recently updated clinical practice guidelines from professional societies such as the American Diabetes Association recommend the use of glucagon-like peptide-1 (GLP-1) receptor agonists prior to insulin when injectable medications are being considered [for type 2 diabetes],” she noted.

“In addition, during the pandemic, patients may not have been seeing their health care providers for routine diabetes care as often as before ... These and other factors may have contributed to the decrease in insulin visits that we observed.”

By specific insulins, glargine has topped the list all along, accounting for about half of all treatment visits, at 52.6% in 2020. Degludec came in second, at 17.4%, and lispro third, at 9.5%.

Use of pen devices also increased

The proportion of treatment visits for insulin vials/syringes declined from 63.9% in 2016 to 41.1% in 2020, while visits for insulin pens rose from 36.1% to 58.7%.

“Many pens are more costly compared to vials of the same insulin product. Interestingly, some studies have found that use of insulin pens may promote greater patient adherence to insulin and, as a result, more broadly decrease health care costs associated with diabetes. However, we did not specifically investigate the cost of insulin in our study,” Dr. Kalyani noted.

The proportion of visits for “newer” insulins, defined as those approved in 2010 or later, rose from 18.1% in 2016 to 40.9% in 2020, while the concurrent drop for insulins approved prior to 2010 was from 81.9% to 59.1%.

“The findings of our study provide insight into potential drivers of insulin costs in the U.S. and may inform health policy,” the researchers conclude.

Funded in part by the National Heart, Lung, and Blood Institute. Dr. Kalyani currently serves on the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration.

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

Despite the extensive recent focus on its cost, insulin use in the United States remains dominated by insulin glargine and other analogs, as well as pen devices for delivery, new research shows.

The findings come from a nationally representative audit of outpatient care with input from nearly 5,000 physicians who prescribed insulin to patients with type 2 diabetes in 2016-2020.

The dramatic rise in the price of insulin in the United States has been extensively discussed in recent years, particularly with the newer analogs as compared with older human insulins.

Few studies indicate analog insulins better than human insulins

“Our findings suggest that even with increased public scrutiny for insulin products ... [the market is] dominated by the use of insulin analogs and insulin pen delivery devices, with persistent uptake of newer products as they are approved,” lead author Rita R. Kalyani, MD, told this news organization.

“Though newer insulins offer potentially greater flexibility with reduced hypoglycemia for many patients, they are also much more costly, with minimal to no head-to-head studies suggesting significant differences in glucose-lowering efficacy when compared to human insulins,” she stressed.

“We found it surprising that, despite the much-publicized concerns regarding insulin costs, analog insulins continue to represent more than 80% of insulin visits in the U.S.” added Dr. Kalyani, of the Division of Endocrinology, Diabetes & Metabolism at Johns Hopkins University School of Medicine, Baltimore.

However, as expected, the study also revealed a gradual increased uptake in the use of biosimilar insulins as more have been introduced to the market.

Dr. Kalyani advised, “Clinicians should be aware of their individual prescribing patterns for insulin and consider the affordability of insulin for patients as part of shared decision-making during clinic visits, particularly given the greater financial strain that many patients have faced during the ongoing COVID-19 pandemic and the rising societal costs for diabetes care.”

The research was published online October 12 in JAMA Network Open by Dr. Kalyani and colleagues.

Analogs prevailed, while biosimilar use rose

The data come from the Health National Disease and Therapeutic Index, a quarterly sampling of approximately 4,800 physicians that provides nationally representative diagnostic and prescribing information on patients treated by office-based physicians in the United States.

Overall, there were 27,860,691 insulin treatment visits for type 2 diabetes in 2016-2020. Of those, long-acting analog insulins (glargine [Lantus], detemir [Levemir], and degludec [Tresiba]) accounted for 67.3% of treatment visits in 2016 and 74.8% of treatment visits in 2020.

Rapid-acting insulin analogs (lispro [Humalog], aspart [Novolog], faster aspart [Fiasp], and glulisine [Apidra]) accounted for about 21.2% of visits in 2016 and about 16.5% in 2020.

On the other hand, intermediate- and short-acting human insulins (NPH and regular) accounted for just 3.7% of visits in 2016 and 2.6% in 2020.

Grouped together, the long- and short-acting analogs accounted for 92.7% of visits in 2016 and 86.3% in 2020, while the human insulins represented just 7.3% of visits in 2016 and 5.5% in 2020.

The biosimilar analog insulins (glargine and lispro) first appeared in the database in 2017, accounting for 2.6% of visits that year and 8.2% by 2020.

Overall, the number of visits for insulin treatment declined by 18% between 2016 and 2020, from 6.0 million to 4.9 million. That drop may be due to multiple factors, Dr. Kalyani said.

“Recently updated clinical practice guidelines from professional societies such as the American Diabetes Association recommend the use of glucagon-like peptide-1 (GLP-1) receptor agonists prior to insulin when injectable medications are being considered [for type 2 diabetes],” she noted.

“In addition, during the pandemic, patients may not have been seeing their health care providers for routine diabetes care as often as before ... These and other factors may have contributed to the decrease in insulin visits that we observed.”

By specific insulins, glargine has topped the list all along, accounting for about half of all treatment visits, at 52.6% in 2020. Degludec came in second, at 17.4%, and lispro third, at 9.5%.

Use of pen devices also increased

The proportion of treatment visits for insulin vials/syringes declined from 63.9% in 2016 to 41.1% in 2020, while visits for insulin pens rose from 36.1% to 58.7%.

“Many pens are more costly compared to vials of the same insulin product. Interestingly, some studies have found that use of insulin pens may promote greater patient adherence to insulin and, as a result, more broadly decrease health care costs associated with diabetes. However, we did not specifically investigate the cost of insulin in our study,” Dr. Kalyani noted.

The proportion of visits for “newer” insulins, defined as those approved in 2010 or later, rose from 18.1% in 2016 to 40.9% in 2020, while the concurrent drop for insulins approved prior to 2010 was from 81.9% to 59.1%.

“The findings of our study provide insight into potential drivers of insulin costs in the U.S. and may inform health policy,” the researchers conclude.

Funded in part by the National Heart, Lung, and Blood Institute. Dr. Kalyani currently serves on the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration.

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

Despite the extensive recent focus on its cost, insulin use in the United States remains dominated by insulin glargine and other analogs, as well as pen devices for delivery, new research shows.

The findings come from a nationally representative audit of outpatient care with input from nearly 5,000 physicians who prescribed insulin to patients with type 2 diabetes in 2016-2020.

The dramatic rise in the price of insulin in the United States has been extensively discussed in recent years, particularly with the newer analogs as compared with older human insulins.

Few studies indicate analog insulins better than human insulins

“Our findings suggest that even with increased public scrutiny for insulin products ... [the market is] dominated by the use of insulin analogs and insulin pen delivery devices, with persistent uptake of newer products as they are approved,” lead author Rita R. Kalyani, MD, told this news organization.

“Though newer insulins offer potentially greater flexibility with reduced hypoglycemia for many patients, they are also much more costly, with minimal to no head-to-head studies suggesting significant differences in glucose-lowering efficacy when compared to human insulins,” she stressed.

“We found it surprising that, despite the much-publicized concerns regarding insulin costs, analog insulins continue to represent more than 80% of insulin visits in the U.S.” added Dr. Kalyani, of the Division of Endocrinology, Diabetes & Metabolism at Johns Hopkins University School of Medicine, Baltimore.

However, as expected, the study also revealed a gradual increased uptake in the use of biosimilar insulins as more have been introduced to the market.

Dr. Kalyani advised, “Clinicians should be aware of their individual prescribing patterns for insulin and consider the affordability of insulin for patients as part of shared decision-making during clinic visits, particularly given the greater financial strain that many patients have faced during the ongoing COVID-19 pandemic and the rising societal costs for diabetes care.”

The research was published online October 12 in JAMA Network Open by Dr. Kalyani and colleagues.

Analogs prevailed, while biosimilar use rose

The data come from the Health National Disease and Therapeutic Index, a quarterly sampling of approximately 4,800 physicians that provides nationally representative diagnostic and prescribing information on patients treated by office-based physicians in the United States.

Overall, there were 27,860,691 insulin treatment visits for type 2 diabetes in 2016-2020. Of those, long-acting analog insulins (glargine [Lantus], detemir [Levemir], and degludec [Tresiba]) accounted for 67.3% of treatment visits in 2016 and 74.8% of treatment visits in 2020.

Rapid-acting insulin analogs (lispro [Humalog], aspart [Novolog], faster aspart [Fiasp], and glulisine [Apidra]) accounted for about 21.2% of visits in 2016 and about 16.5% in 2020.

On the other hand, intermediate- and short-acting human insulins (NPH and regular) accounted for just 3.7% of visits in 2016 and 2.6% in 2020.

Grouped together, the long- and short-acting analogs accounted for 92.7% of visits in 2016 and 86.3% in 2020, while the human insulins represented just 7.3% of visits in 2016 and 5.5% in 2020.

The biosimilar analog insulins (glargine and lispro) first appeared in the database in 2017, accounting for 2.6% of visits that year and 8.2% by 2020.

Overall, the number of visits for insulin treatment declined by 18% between 2016 and 2020, from 6.0 million to 4.9 million. That drop may be due to multiple factors, Dr. Kalyani said.

“Recently updated clinical practice guidelines from professional societies such as the American Diabetes Association recommend the use of glucagon-like peptide-1 (GLP-1) receptor agonists prior to insulin when injectable medications are being considered [for type 2 diabetes],” she noted.

“In addition, during the pandemic, patients may not have been seeing their health care providers for routine diabetes care as often as before ... These and other factors may have contributed to the decrease in insulin visits that we observed.”

By specific insulins, glargine has topped the list all along, accounting for about half of all treatment visits, at 52.6% in 2020. Degludec came in second, at 17.4%, and lispro third, at 9.5%.

Use of pen devices also increased

The proportion of treatment visits for insulin vials/syringes declined from 63.9% in 2016 to 41.1% in 2020, while visits for insulin pens rose from 36.1% to 58.7%.

“Many pens are more costly compared to vials of the same insulin product. Interestingly, some studies have found that use of insulin pens may promote greater patient adherence to insulin and, as a result, more broadly decrease health care costs associated with diabetes. However, we did not specifically investigate the cost of insulin in our study,” Dr. Kalyani noted.

The proportion of visits for “newer” insulins, defined as those approved in 2010 or later, rose from 18.1% in 2016 to 40.9% in 2020, while the concurrent drop for insulins approved prior to 2010 was from 81.9% to 59.1%.

“The findings of our study provide insight into potential drivers of insulin costs in the U.S. and may inform health policy,” the researchers conclude.

Funded in part by the National Heart, Lung, and Blood Institute. Dr. Kalyani currently serves on the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration.

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

It’s hard for people to completely escape a history of obesity, even when they later achieve a healthy weight.

American adults who once had obesity but later achieved and maintained a healthy body mass index (BMI) normalized some, but not all, of the excess clinical risk associated with obesity in a review of data collected from about 20,000 people during a series of eight NHANES surveys.

Maia P. Smith, MD, reported the findings at the virtual European Association for the Study of Diabetes (EASD) 2021 Annual Meeting.

“For some conditions, such as hypertension and dyslipidemia, the recovery [following a sharp drop in BMI] appears to be total, while for other conditions, like diabetes, the recovery is probabilistic. Some recover, but some don’t,” explained Dr. Smith in an interview.

“Weight loss reverses all, or essentially all, of the damage done by obesity in some people, but does not cause full reversal of the harm and does not fully resolve [type 2] diabetes in many others,” added Dr. Smith, an epidemiologist in the Department of Public Health and Preventive Medicine at St. George’s University, Grenada.

“The fact that ... analyses comparing formerly obese people to normal weight populations demonstrated improvement in population mean levels of hypertension and dyslipidemia is remarkable,” commented Rebecca T. Emeny, PhD, an epidemiologist at the Dartmouth Institute of Health Policy and Clinical Practice in Lebanon, New Hampshire, who was not involved with Dr. Smith’s study.

“The observation that the individuals who were able to maintain normal weight after past obesity were still at greater risk for diabetes compared with the normal weight group speaks to the recent discussion of obesity as a metabolic disorder rather than a problem of calories in and calories out,” said Dr. Emeny in an interview.

She cited a recent article that proposed a carbohydrate-insulin model for obesity in place of an energy-balance model. This, however, is still somewhat contentious.

Dr. Emeny also cautioned that “the results of this study compare populations. The design and analysis do not allow for interpretation of individual risk resulting from changes in weight.”
 

Those who formerly had obesity can reverse hypertension, dyslipidemia

The study by Dr. Smith and associates used data collected in the National Health and Nutrition Examination Survey (NHANES), which is performed every 2 years by the U.S. Centers for Disease Control and Prevention.

They used data from eight consecutive surveys starting in 1999-2000 and continuing through 2013-2014, yielding data from nearly 40,000 adults who were at least 20 years old.

In addition to the 326 people who formerly had obesity at some time previously during their life (BMI ≥30 kg/m²) but now had a healthy BMI, and 6,235 who were consistently at a healthy BMI, they also included 13,710 people who currently had obesity. They dropped the remaining survey participants who did not fit into one of these three categories.

The participants who formerly had obesity averaged 54 years old, compared with a mean age of 48 years among those with current obesity and 41 years among those who currently had a healthy BMI (who had never had obesity). The results showed no differences by sex, but those who formerly had obesity had a much higher smoking prevalence.

The people who reported a healthy BMI (18.5-24.9 kg/m²) after previously having obesity had current prevalence rates of hypertension and dyslipidemia that were, respectively, 8% and 13% higher than the prevalence rates among adults who consistently maintained a healthy BMI – differences that were not significant.

In contrast, people who had current BMIs that indicated obesity had prevalence rates of hypertension and dyslipidemia that were each a significant threefold higher than those with a healthy BMI.

The 326 respondents who formerly had obesity but now were at a healthy BMI had a threefold higher prevalence of diabetes than did the 6,235 who consistently had maintained a healthy BMI. This was substantially less than the over sevenfold higher prevalence of diabetes among those who currently had obesity compared with those who always had a healthy BMI.

All these analyses were adjusted for the potential confounders of age, sex, smoking history, and ethnicity.
 

‘Quitting’ obesity better than current obesity

The finding that reaching a healthy BMI after a period of obesity could reverse some but not all risks associated with obesity is reminiscent of the effects of smoking, noted Dr. Smith.

“Never is better than ever, but quitting,” or dropping weight to reach a healthy BMI, “is better than current,” she concluded.

But Dr. Emeny said this interpretation, “while motivating and catchy, places emphasis on individual responsibility and choice rather than on social circumstances.”

Social effects “must be considered when evaluating population-level disparities in obesity-related cardiometabolic risk,” cautioned Dr. Emeny.

“’Quitting’ obesity is much more complicated than individual choice or ability.”

Dr. Smith also conceded that her analyses did not correct for the possible confounding effects that changes in diet or physical activity may have had on the observations.

“Neither diet nor physical activity has a well-known summary measure that we could have included as an adjuster,” she explained.

Dr. Smith and Dr. Emeny have reported no relevant financial relationships.

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

It’s hard for people to completely escape a history of obesity, even when they later achieve a healthy weight.

American adults who once had obesity but later achieved and maintained a healthy body mass index (BMI) normalized some, but not all, of the excess clinical risk associated with obesity in a review of data collected from about 20,000 people during a series of eight NHANES surveys.

Maia P. Smith, MD, reported the findings at the virtual European Association for the Study of Diabetes (EASD) 2021 Annual Meeting.

“For some conditions, such as hypertension and dyslipidemia, the recovery [following a sharp drop in BMI] appears to be total, while for other conditions, like diabetes, the recovery is probabilistic. Some recover, but some don’t,” explained Dr. Smith in an interview.

“Weight loss reverses all, or essentially all, of the damage done by obesity in some people, but does not cause full reversal of the harm and does not fully resolve [type 2] diabetes in many others,” added Dr. Smith, an epidemiologist in the Department of Public Health and Preventive Medicine at St. George’s University, Grenada.

“The fact that ... analyses comparing formerly obese people to normal weight populations demonstrated improvement in population mean levels of hypertension and dyslipidemia is remarkable,” commented Rebecca T. Emeny, PhD, an epidemiologist at the Dartmouth Institute of Health Policy and Clinical Practice in Lebanon, New Hampshire, who was not involved with Dr. Smith’s study.

“The observation that the individuals who were able to maintain normal weight after past obesity were still at greater risk for diabetes compared with the normal weight group speaks to the recent discussion of obesity as a metabolic disorder rather than a problem of calories in and calories out,” said Dr. Emeny in an interview.

She cited a recent article that proposed a carbohydrate-insulin model for obesity in place of an energy-balance model. This, however, is still somewhat contentious.

Dr. Emeny also cautioned that “the results of this study compare populations. The design and analysis do not allow for interpretation of individual risk resulting from changes in weight.”
 

Those who formerly had obesity can reverse hypertension, dyslipidemia

The study by Dr. Smith and associates used data collected in the National Health and Nutrition Examination Survey (NHANES), which is performed every 2 years by the U.S. Centers for Disease Control and Prevention.

They used data from eight consecutive surveys starting in 1999-2000 and continuing through 2013-2014, yielding data from nearly 40,000 adults who were at least 20 years old.

In addition to the 326 people who formerly had obesity at some time previously during their life (BMI ≥30 kg/m²) but now had a healthy BMI, and 6,235 who were consistently at a healthy BMI, they also included 13,710 people who currently had obesity. They dropped the remaining survey participants who did not fit into one of these three categories.

The participants who formerly had obesity averaged 54 years old, compared with a mean age of 48 years among those with current obesity and 41 years among those who currently had a healthy BMI (who had never had obesity). The results showed no differences by sex, but those who formerly had obesity had a much higher smoking prevalence.

The people who reported a healthy BMI (18.5-24.9 kg/m²) after previously having obesity had current prevalence rates of hypertension and dyslipidemia that were, respectively, 8% and 13% higher than the prevalence rates among adults who consistently maintained a healthy BMI – differences that were not significant.

In contrast, people who had current BMIs that indicated obesity had prevalence rates of hypertension and dyslipidemia that were each a significant threefold higher than those with a healthy BMI.

The 326 respondents who formerly had obesity but now were at a healthy BMI had a threefold higher prevalence of diabetes than did the 6,235 who consistently had maintained a healthy BMI. This was substantially less than the over sevenfold higher prevalence of diabetes among those who currently had obesity compared with those who always had a healthy BMI.

All these analyses were adjusted for the potential confounders of age, sex, smoking history, and ethnicity.
 

‘Quitting’ obesity better than current obesity

The finding that reaching a healthy BMI after a period of obesity could reverse some but not all risks associated with obesity is reminiscent of the effects of smoking, noted Dr. Smith.

“Never is better than ever, but quitting,” or dropping weight to reach a healthy BMI, “is better than current,” she concluded.

But Dr. Emeny said this interpretation, “while motivating and catchy, places emphasis on individual responsibility and choice rather than on social circumstances.”

Social effects “must be considered when evaluating population-level disparities in obesity-related cardiometabolic risk,” cautioned Dr. Emeny.

“’Quitting’ obesity is much more complicated than individual choice or ability.”

Dr. Smith also conceded that her analyses did not correct for the possible confounding effects that changes in diet or physical activity may have had on the observations.

“Neither diet nor physical activity has a well-known summary measure that we could have included as an adjuster,” she explained.

Dr. Smith and Dr. Emeny have reported no relevant financial relationships.

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

It’s hard for people to completely escape a history of obesity, even when they later achieve a healthy weight.

American adults who once had obesity but later achieved and maintained a healthy body mass index (BMI) normalized some, but not all, of the excess clinical risk associated with obesity in a review of data collected from about 20,000 people during a series of eight NHANES surveys.

Maia P. Smith, MD, reported the findings at the virtual European Association for the Study of Diabetes (EASD) 2021 Annual Meeting.

“For some conditions, such as hypertension and dyslipidemia, the recovery [following a sharp drop in BMI] appears to be total, while for other conditions, like diabetes, the recovery is probabilistic. Some recover, but some don’t,” explained Dr. Smith in an interview.

“Weight loss reverses all, or essentially all, of the damage done by obesity in some people, but does not cause full reversal of the harm and does not fully resolve [type 2] diabetes in many others,” added Dr. Smith, an epidemiologist in the Department of Public Health and Preventive Medicine at St. George’s University, Grenada.

“The fact that ... analyses comparing formerly obese people to normal weight populations demonstrated improvement in population mean levels of hypertension and dyslipidemia is remarkable,” commented Rebecca T. Emeny, PhD, an epidemiologist at the Dartmouth Institute of Health Policy and Clinical Practice in Lebanon, New Hampshire, who was not involved with Dr. Smith’s study.

“The observation that the individuals who were able to maintain normal weight after past obesity were still at greater risk for diabetes compared with the normal weight group speaks to the recent discussion of obesity as a metabolic disorder rather than a problem of calories in and calories out,” said Dr. Emeny in an interview.

She cited a recent article that proposed a carbohydrate-insulin model for obesity in place of an energy-balance model. This, however, is still somewhat contentious.

Dr. Emeny also cautioned that “the results of this study compare populations. The design and analysis do not allow for interpretation of individual risk resulting from changes in weight.”
 

Those who formerly had obesity can reverse hypertension, dyslipidemia

The study by Dr. Smith and associates used data collected in the National Health and Nutrition Examination Survey (NHANES), which is performed every 2 years by the U.S. Centers for Disease Control and Prevention.

They used data from eight consecutive surveys starting in 1999-2000 and continuing through 2013-2014, yielding data from nearly 40,000 adults who were at least 20 years old.

In addition to the 326 people who formerly had obesity at some time previously during their life (BMI ≥30 kg/m²) but now had a healthy BMI, and 6,235 who were consistently at a healthy BMI, they also included 13,710 people who currently had obesity. They dropped the remaining survey participants who did not fit into one of these three categories.

The participants who formerly had obesity averaged 54 years old, compared with a mean age of 48 years among those with current obesity and 41 years among those who currently had a healthy BMI (who had never had obesity). The results showed no differences by sex, but those who formerly had obesity had a much higher smoking prevalence.

The people who reported a healthy BMI (18.5-24.9 kg/m²) after previously having obesity had current prevalence rates of hypertension and dyslipidemia that were, respectively, 8% and 13% higher than the prevalence rates among adults who consistently maintained a healthy BMI – differences that were not significant.

In contrast, people who had current BMIs that indicated obesity had prevalence rates of hypertension and dyslipidemia that were each a significant threefold higher than those with a healthy BMI.

The 326 respondents who formerly had obesity but now were at a healthy BMI had a threefold higher prevalence of diabetes than did the 6,235 who consistently had maintained a healthy BMI. This was substantially less than the over sevenfold higher prevalence of diabetes among those who currently had obesity compared with those who always had a healthy BMI.

All these analyses were adjusted for the potential confounders of age, sex, smoking history, and ethnicity.
 

‘Quitting’ obesity better than current obesity

The finding that reaching a healthy BMI after a period of obesity could reverse some but not all risks associated with obesity is reminiscent of the effects of smoking, noted Dr. Smith.

“Never is better than ever, but quitting,” or dropping weight to reach a healthy BMI, “is better than current,” she concluded.

But Dr. Emeny said this interpretation, “while motivating and catchy, places emphasis on individual responsibility and choice rather than on social circumstances.”

Social effects “must be considered when evaluating population-level disparities in obesity-related cardiometabolic risk,” cautioned Dr. Emeny.

“’Quitting’ obesity is much more complicated than individual choice or ability.”

Dr. Smith also conceded that her analyses did not correct for the possible confounding effects that changes in diet or physical activity may have had on the observations.

“Neither diet nor physical activity has a well-known summary measure that we could have included as an adjuster,” she explained.

Dr. Smith and Dr. Emeny have reported no relevant financial relationships.

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

Let me tell you a story. In 5 billion years the sun will run out of hydrogen, the fuel it is currently burning to power my solar panels amongst other things. At that time, the sun will no longer be able to keep its core contracted and will expand into a fiery, red giant, engulfing earth and obliterating any sign that we ever existed. No buildings. No blog posts. No mausoleums. No stories. Nothing of us will remain.

Well, here for a moment anyway, I’ve gotten you to think about something other than COVID. You’re welcome.

Fascinatingly, the image in your mind’s eye right now of a barren scorched landscape was put there by me. Simply by placing a few words together I have caused new thoughts in your head. You might even share this story with someone else – I would have actually changed your behavior through the power of language. This miraculous phenomenon seems to be unique to us humans; we are the only ones who can create whole worlds in another individual’s head just by making a few sounds. We in medicine have the privilege of experiencing this miracle every day.

Last week, a 97-year-old pale, frail, white man saw me for a basal cell carcinoma on his cheek. While performing a simple electrodesiccation and curettage, I asked if he remembers getting a lot of sunburns when he was young. He certainly remembered one. On a blustery sunny day, he fell asleep for hours on the deck of the USS West Virginia while in the Philippines. As a radio man, he was exhausted from days of conflict and he recalled how warm breezes lulled him asleep. He was so sunburned that for days he forgot how afraid he was of the Japanese.

After listening to his story, I had an image in my mind of palm trees swaying in the tropical winds while hundreds of hulking gray castles sat hidden in the vast surrounding oceans awaiting one of the greatest naval conflicts in history. I got to hear it from surely one of the last remaining people in existence to be able to tell that story. Listening to a patient’s tales is one of the benefits of being a physician. Not only do they help bond us with our patients, but also help lessen our burden of having to make diagnosis after diagnosis and write note after note for hours on end. Somehow performing yet another biopsy that day is made just a bit easier if I’m also learning about what it was like at the Battle of Leyte Gulf.

Encouraging patients to talk more can be risky. No physician, not even allergists, can afford to be waylaid by a retiree with nothing else to do today. But meaningful encounters can not only be a vaccine against burnout, they also lead to better patient adherence and satisfaction. Sometimes, there is simply not time. But often there is a little window during a procedure or when you’re reasonably caught up and don’t expect delays ahead. When patients say that a doctor really listened to me, it is often not their medical history, but their life story they mean. And like every story, they literally transform us, the listener. In a true physical sense, their stories live on in me, and now that I’ve shared this one in writing, also with you for perpetuity. That is at least for the next 5 billion years when it, too, will be swallowed by the sun, leaving only a crispy, smoking rock where we once existed.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

Let me tell you a story. In 5 billion years the sun will run out of hydrogen, the fuel it is currently burning to power my solar panels amongst other things. At that time, the sun will no longer be able to keep its core contracted and will expand into a fiery, red giant, engulfing earth and obliterating any sign that we ever existed. No buildings. No blog posts. No mausoleums. No stories. Nothing of us will remain.

Well, here for a moment anyway, I’ve gotten you to think about something other than COVID. You’re welcome.

Fascinatingly, the image in your mind’s eye right now of a barren scorched landscape was put there by me. Simply by placing a few words together I have caused new thoughts in your head. You might even share this story with someone else – I would have actually changed your behavior through the power of language. This miraculous phenomenon seems to be unique to us humans; we are the only ones who can create whole worlds in another individual’s head just by making a few sounds. We in medicine have the privilege of experiencing this miracle every day.

Last week, a 97-year-old pale, frail, white man saw me for a basal cell carcinoma on his cheek. While performing a simple electrodesiccation and curettage, I asked if he remembers getting a lot of sunburns when he was young. He certainly remembered one. On a blustery sunny day, he fell asleep for hours on the deck of the USS West Virginia while in the Philippines. As a radio man, he was exhausted from days of conflict and he recalled how warm breezes lulled him asleep. He was so sunburned that for days he forgot how afraid he was of the Japanese.

After listening to his story, I had an image in my mind of palm trees swaying in the tropical winds while hundreds of hulking gray castles sat hidden in the vast surrounding oceans awaiting one of the greatest naval conflicts in history. I got to hear it from surely one of the last remaining people in existence to be able to tell that story. Listening to a patient’s tales is one of the benefits of being a physician. Not only do they help bond us with our patients, but also help lessen our burden of having to make diagnosis after diagnosis and write note after note for hours on end. Somehow performing yet another biopsy that day is made just a bit easier if I’m also learning about what it was like at the Battle of Leyte Gulf.

Encouraging patients to talk more can be risky. No physician, not even allergists, can afford to be waylaid by a retiree with nothing else to do today. But meaningful encounters can not only be a vaccine against burnout, they also lead to better patient adherence and satisfaction. Sometimes, there is simply not time. But often there is a little window during a procedure or when you’re reasonably caught up and don’t expect delays ahead. When patients say that a doctor really listened to me, it is often not their medical history, but their life story they mean. And like every story, they literally transform us, the listener. In a true physical sense, their stories live on in me, and now that I’ve shared this one in writing, also with you for perpetuity. That is at least for the next 5 billion years when it, too, will be swallowed by the sun, leaving only a crispy, smoking rock where we once existed.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

Let me tell you a story. In 5 billion years the sun will run out of hydrogen, the fuel it is currently burning to power my solar panels amongst other things. At that time, the sun will no longer be able to keep its core contracted and will expand into a fiery, red giant, engulfing earth and obliterating any sign that we ever existed. No buildings. No blog posts. No mausoleums. No stories. Nothing of us will remain.

Well, here for a moment anyway, I’ve gotten you to think about something other than COVID. You’re welcome.

Fascinatingly, the image in your mind’s eye right now of a barren scorched landscape was put there by me. Simply by placing a few words together I have caused new thoughts in your head. You might even share this story with someone else – I would have actually changed your behavior through the power of language. This miraculous phenomenon seems to be unique to us humans; we are the only ones who can create whole worlds in another individual’s head just by making a few sounds. We in medicine have the privilege of experiencing this miracle every day.

Last week, a 97-year-old pale, frail, white man saw me for a basal cell carcinoma on his cheek. While performing a simple electrodesiccation and curettage, I asked if he remembers getting a lot of sunburns when he was young. He certainly remembered one. On a blustery sunny day, he fell asleep for hours on the deck of the USS West Virginia while in the Philippines. As a radio man, he was exhausted from days of conflict and he recalled how warm breezes lulled him asleep. He was so sunburned that for days he forgot how afraid he was of the Japanese.

After listening to his story, I had an image in my mind of palm trees swaying in the tropical winds while hundreds of hulking gray castles sat hidden in the vast surrounding oceans awaiting one of the greatest naval conflicts in history. I got to hear it from surely one of the last remaining people in existence to be able to tell that story. Listening to a patient’s tales is one of the benefits of being a physician. Not only do they help bond us with our patients, but also help lessen our burden of having to make diagnosis after diagnosis and write note after note for hours on end. Somehow performing yet another biopsy that day is made just a bit easier if I’m also learning about what it was like at the Battle of Leyte Gulf.

Encouraging patients to talk more can be risky. No physician, not even allergists, can afford to be waylaid by a retiree with nothing else to do today. But meaningful encounters can not only be a vaccine against burnout, they also lead to better patient adherence and satisfaction. Sometimes, there is simply not time. But often there is a little window during a procedure or when you’re reasonably caught up and don’t expect delays ahead. When patients say that a doctor really listened to me, it is often not their medical history, but their life story they mean. And like every story, they literally transform us, the listener. In a true physical sense, their stories live on in me, and now that I’ve shared this one in writing, also with you for perpetuity. That is at least for the next 5 billion years when it, too, will be swallowed by the sun, leaving only a crispy, smoking rock where we once existed.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

After a heart attack, the damaged area of the heart often becomes scar tissue that can’t receive electrical messages to contract and pump blood to the body. The result is a weakened heart that could get an irregular beat, known as an arrhythmia, or go into failure.

Right now, doctors have two imperfect options for repairing this damaged tissue. One is to surgically implant a scaffold that conducts electrically and bridges the heart’s signaling system past the dead tissue. But these implants require open-chest surgery, which is risky and can lead to other heart problems.

Clinicians can use an approach that avoids opening the chest, but the patch used for these procedures may not hold its shape when grafted to damaged tissue.

Now, scientists may be working on a fix that promises the best of both worlds: an injectable patch that conducts electricity and keeps its shape once grafted to heart muscle.

The patch hasn’t been tested in humans -- any such trials are still a long way off -- but early results in animals show potential.

This experimental patch can be rolled up, threaded into a catheter or a syringe, and injected into damaged heart tissue, where it unfurls and attaches to the muscle. Once in place, the patch supports normal heart function, according to results from studies using rats and pigs. The findings were published in Nature Biomedical Engineering.

When researchers placed the patch on damaged heart muscle in rats, they found this fix resulted in a return to mostly normal heart function within 4 weeks. Results were similar when scientists tested the patch in a small number of pigs, which are considered to resemble humans more closely than rodents.

The patched hearts did a better job in pumping oxygen-rich blood to the body, and the amount of heart tissue that wasn’t getting enough oxygen also declined.

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

After a heart attack, the damaged area of the heart often becomes scar tissue that can’t receive electrical messages to contract and pump blood to the body. The result is a weakened heart that could get an irregular beat, known as an arrhythmia, or go into failure.

Right now, doctors have two imperfect options for repairing this damaged tissue. One is to surgically implant a scaffold that conducts electrically and bridges the heart’s signaling system past the dead tissue. But these implants require open-chest surgery, which is risky and can lead to other heart problems.

Clinicians can use an approach that avoids opening the chest, but the patch used for these procedures may not hold its shape when grafted to damaged tissue.

Now, scientists may be working on a fix that promises the best of both worlds: an injectable patch that conducts electricity and keeps its shape once grafted to heart muscle.

The patch hasn’t been tested in humans -- any such trials are still a long way off -- but early results in animals show potential.

This experimental patch can be rolled up, threaded into a catheter or a syringe, and injected into damaged heart tissue, where it unfurls and attaches to the muscle. Once in place, the patch supports normal heart function, according to results from studies using rats and pigs. The findings were published in Nature Biomedical Engineering.

When researchers placed the patch on damaged heart muscle in rats, they found this fix resulted in a return to mostly normal heart function within 4 weeks. Results were similar when scientists tested the patch in a small number of pigs, which are considered to resemble humans more closely than rodents.

The patched hearts did a better job in pumping oxygen-rich blood to the body, and the amount of heart tissue that wasn’t getting enough oxygen also declined.

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

After a heart attack, the damaged area of the heart often becomes scar tissue that can’t receive electrical messages to contract and pump blood to the body. The result is a weakened heart that could get an irregular beat, known as an arrhythmia, or go into failure.

Right now, doctors have two imperfect options for repairing this damaged tissue. One is to surgically implant a scaffold that conducts electrically and bridges the heart’s signaling system past the dead tissue. But these implants require open-chest surgery, which is risky and can lead to other heart problems.

Clinicians can use an approach that avoids opening the chest, but the patch used for these procedures may not hold its shape when grafted to damaged tissue.

Now, scientists may be working on a fix that promises the best of both worlds: an injectable patch that conducts electricity and keeps its shape once grafted to heart muscle.

The patch hasn’t been tested in humans -- any such trials are still a long way off -- but early results in animals show potential.

This experimental patch can be rolled up, threaded into a catheter or a syringe, and injected into damaged heart tissue, where it unfurls and attaches to the muscle. Once in place, the patch supports normal heart function, according to results from studies using rats and pigs. The findings were published in Nature Biomedical Engineering.

When researchers placed the patch on damaged heart muscle in rats, they found this fix resulted in a return to mostly normal heart function within 4 weeks. Results were similar when scientists tested the patch in a small number of pigs, which are considered to resemble humans more closely than rodents.

The patched hearts did a better job in pumping oxygen-rich blood to the body, and the amount of heart tissue that wasn’t getting enough oxygen also declined.

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

For patients with refractory acute respiratory distress syndrome (ARDS) caused by COVID-19 infections, extracorporeal membrane oxygenation (ECMO) may be the treatment of last resort.

But for reasons that aren’t clear, in the second wave of the COVID-19 pandemic at a major teaching hospital, the mortality rate of patients on ECMO for COVID-induced ARDS was significantly higher than it was during the first wave, despite changes in drug therapy and clinical management, reported Rohit Reddy, BS, a second-year medical student, and colleagues at Thomas Jefferson University Hospital in Philadelphia.

During the first wave, from April to September 2020, the survival rate of patients while on ECMO in their ICUs was 67%. In contrast, for patients treated during the second wave, from November 2020 to March 2021, the ECMO survival rate was 31% (P = .003).

The 30-day survival rates were also higher in the first wave compared with the second, at 54% versus 31%, but this difference was not statistically significant.

“More research is required to develop stricter inclusion/exclusion criteria and to improve pre-ECMO management in order to improve outcomes,” Mr. Reddy said in a narrated poster presented at the annual meeting of the American College of Chest Physicians, held virtually this year.
 

ARDS severity higher

ARDS is a major complication of COVID-19 infections, and there is evidence to suggest that COVID-associated ARDS is more severe than ARDS caused by other causes, the investigators noted.

“ECMO, which has been used as a rescue therapy in prior viral outbreaks, has been used to support certain patients with refractory ARDS due to COVID-19, but evidence for its efficacy is limited. Respiratory failure remained a highly concerning complication in the second wave of the COVID-19 pandemic, but it is unclear how the evolution of the disease and pharmacologic utility has affected the clinical utility of ECMO,” Mr. Reddy said.

To see whether changes in disease course or in treatment could explain changes in outcomes for patients with COVID-related ARDS, the investigators compared characteristics and outcomes for patients treated in the first versus second waves of the pandemic. Their study did not include data from patients infected with the Delta variant of the SARS-CoV-2 virus, which became the predominant viral strain later in 2021.

The study included data on 28 patients treated during the first wave, and 13 during the second. The sample included 28 men and 13 women with a mean age of 51 years.

All patients had venovenous ECMO, with cannulation in the femoral or internal jugular veins; some patients received ECMO via a single double-lumen cannula.

There were no significant differences between the two time periods in patient comorbidities prior to initiation of ECMO.

Patients in the second wave were significantly more likely to receive steroids (54% vs. 100%; P = .003) and remdesivir (39% vs. 85%; P = .007). Prone positioning before ECMO was also significantly more frequent in the second wave (11% vs. 85%; P < .001).

Patients in the second wave stayed on ECMO longer – median 20 days versus 14 days for first-wave patients – but as noted before, ECMO mortality rates were significantly higher during the second wave. During the first wave, 33% of patients died while on ECMO, compared with 69% in the second wave (P = .03). Respective 30-day mortality rates were 46% versus 69% (ns).

Rates of complications during ECMO were generally comparable between the groups, including acute renal failure (39% in the first wave vs 38% in the second), sepsis (32% vs. 23%), bacterial pneumonia (11% vs. 8%), and gastrointestinal bleeding (21% vs. 15%). However, significantly more patients in the second wave had cerebral vascular accidents (4% vs. 23%; P = .050).

Senior author Hitoshi Hirose, MD, PhD, professor of surgery at Thomas Jefferson University, said in an interview that the difference in outcomes was likely caused by changes in pre-ECMO therapy between the first and second waves.

“Our study showed the incidence of sepsis had a large impact on the patient outcomes,” he wrote. “We speculate that sepsis was attributed to use of immune modulation therapy. The prevention of the sepsis would be key to improve survival of ECMO for COVID 19.”

“It’s possible that the explanation for this is that patients in the second wave were sicker in a way that wasn’t adequately measured in the first wave,” CHEST 2021 program cochair Christopher Carroll, MD, FCCP, from Connecticut Children’s Medical Center in Hartford, said in an interview.

The differences may also have been attributable to changes in virulence, or to clinical decisions to put sicker patients on ECMO, he said.

Casey Cable, MD, MSc, a pulmonary disease and critical care specialist at Virginia Commonwealth Medical Center in Richmond, also speculated in an interview that second-wave patients may have been sicker.

“One interesting piece of this story is that we now know a lot more – we know about the use of steroids plus or minus remdesivir and proning, and patients received a large majority of those treatments but still got put on ECMO,” she said. “I wonder if there is a subset of really sick patients, and no matter what we treat with – steroids, proning – whatever we do they’re just not going to do well.”

Both Dr. Carroll and Dr. Cable emphasized the importance of ECMO as a rescue therapy for patients with severe, refractory ARDS associated with COVID-19 or other diseases.

Neither Dr. Carroll nor Dr. Cable were involved in the study.

No study funding was reported. Mr. Reddy, Dr. Hirose, Dr. Carroll, and Dr. Cable disclosed no relevant financial relationships.

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

For patients with refractory acute respiratory distress syndrome (ARDS) caused by COVID-19 infections, extracorporeal membrane oxygenation (ECMO) may be the treatment of last resort.

But for reasons that aren’t clear, in the second wave of the COVID-19 pandemic at a major teaching hospital, the mortality rate of patients on ECMO for COVID-induced ARDS was significantly higher than it was during the first wave, despite changes in drug therapy and clinical management, reported Rohit Reddy, BS, a second-year medical student, and colleagues at Thomas Jefferson University Hospital in Philadelphia.

During the first wave, from April to September 2020, the survival rate of patients while on ECMO in their ICUs was 67%. In contrast, for patients treated during the second wave, from November 2020 to March 2021, the ECMO survival rate was 31% (P = .003).

The 30-day survival rates were also higher in the first wave compared with the second, at 54% versus 31%, but this difference was not statistically significant.

“More research is required to develop stricter inclusion/exclusion criteria and to improve pre-ECMO management in order to improve outcomes,” Mr. Reddy said in a narrated poster presented at the annual meeting of the American College of Chest Physicians, held virtually this year.
 

ARDS severity higher

ARDS is a major complication of COVID-19 infections, and there is evidence to suggest that COVID-associated ARDS is more severe than ARDS caused by other causes, the investigators noted.

“ECMO, which has been used as a rescue therapy in prior viral outbreaks, has been used to support certain patients with refractory ARDS due to COVID-19, but evidence for its efficacy is limited. Respiratory failure remained a highly concerning complication in the second wave of the COVID-19 pandemic, but it is unclear how the evolution of the disease and pharmacologic utility has affected the clinical utility of ECMO,” Mr. Reddy said.

To see whether changes in disease course or in treatment could explain changes in outcomes for patients with COVID-related ARDS, the investigators compared characteristics and outcomes for patients treated in the first versus second waves of the pandemic. Their study did not include data from patients infected with the Delta variant of the SARS-CoV-2 virus, which became the predominant viral strain later in 2021.

The study included data on 28 patients treated during the first wave, and 13 during the second. The sample included 28 men and 13 women with a mean age of 51 years.

All patients had venovenous ECMO, with cannulation in the femoral or internal jugular veins; some patients received ECMO via a single double-lumen cannula.

There were no significant differences between the two time periods in patient comorbidities prior to initiation of ECMO.

Patients in the second wave were significantly more likely to receive steroids (54% vs. 100%; P = .003) and remdesivir (39% vs. 85%; P = .007). Prone positioning before ECMO was also significantly more frequent in the second wave (11% vs. 85%; P < .001).

Patients in the second wave stayed on ECMO longer – median 20 days versus 14 days for first-wave patients – but as noted before, ECMO mortality rates were significantly higher during the second wave. During the first wave, 33% of patients died while on ECMO, compared with 69% in the second wave (P = .03). Respective 30-day mortality rates were 46% versus 69% (ns).

Rates of complications during ECMO were generally comparable between the groups, including acute renal failure (39% in the first wave vs 38% in the second), sepsis (32% vs. 23%), bacterial pneumonia (11% vs. 8%), and gastrointestinal bleeding (21% vs. 15%). However, significantly more patients in the second wave had cerebral vascular accidents (4% vs. 23%; P = .050).

Senior author Hitoshi Hirose, MD, PhD, professor of surgery at Thomas Jefferson University, said in an interview that the difference in outcomes was likely caused by changes in pre-ECMO therapy between the first and second waves.

“Our study showed the incidence of sepsis had a large impact on the patient outcomes,” he wrote. “We speculate that sepsis was attributed to use of immune modulation therapy. The prevention of the sepsis would be key to improve survival of ECMO for COVID 19.”

“It’s possible that the explanation for this is that patients in the second wave were sicker in a way that wasn’t adequately measured in the first wave,” CHEST 2021 program cochair Christopher Carroll, MD, FCCP, from Connecticut Children’s Medical Center in Hartford, said in an interview.

The differences may also have been attributable to changes in virulence, or to clinical decisions to put sicker patients on ECMO, he said.

Casey Cable, MD, MSc, a pulmonary disease and critical care specialist at Virginia Commonwealth Medical Center in Richmond, also speculated in an interview that second-wave patients may have been sicker.

“One interesting piece of this story is that we now know a lot more – we know about the use of steroids plus or minus remdesivir and proning, and patients received a large majority of those treatments but still got put on ECMO,” she said. “I wonder if there is a subset of really sick patients, and no matter what we treat with – steroids, proning – whatever we do they’re just not going to do well.”

Both Dr. Carroll and Dr. Cable emphasized the importance of ECMO as a rescue therapy for patients with severe, refractory ARDS associated with COVID-19 or other diseases.

Neither Dr. Carroll nor Dr. Cable were involved in the study.

No study funding was reported. Mr. Reddy, Dr. Hirose, Dr. Carroll, and Dr. Cable disclosed no relevant financial relationships.

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

For patients with refractory acute respiratory distress syndrome (ARDS) caused by COVID-19 infections, extracorporeal membrane oxygenation (ECMO) may be the treatment of last resort.

But for reasons that aren’t clear, in the second wave of the COVID-19 pandemic at a major teaching hospital, the mortality rate of patients on ECMO for COVID-induced ARDS was significantly higher than it was during the first wave, despite changes in drug therapy and clinical management, reported Rohit Reddy, BS, a second-year medical student, and colleagues at Thomas Jefferson University Hospital in Philadelphia.

During the first wave, from April to September 2020, the survival rate of patients while on ECMO in their ICUs was 67%. In contrast, for patients treated during the second wave, from November 2020 to March 2021, the ECMO survival rate was 31% (P = .003).

The 30-day survival rates were also higher in the first wave compared with the second, at 54% versus 31%, but this difference was not statistically significant.

“More research is required to develop stricter inclusion/exclusion criteria and to improve pre-ECMO management in order to improve outcomes,” Mr. Reddy said in a narrated poster presented at the annual meeting of the American College of Chest Physicians, held virtually this year.
 

ARDS severity higher

ARDS is a major complication of COVID-19 infections, and there is evidence to suggest that COVID-associated ARDS is more severe than ARDS caused by other causes, the investigators noted.

“ECMO, which has been used as a rescue therapy in prior viral outbreaks, has been used to support certain patients with refractory ARDS due to COVID-19, but evidence for its efficacy is limited. Respiratory failure remained a highly concerning complication in the second wave of the COVID-19 pandemic, but it is unclear how the evolution of the disease and pharmacologic utility has affected the clinical utility of ECMO,” Mr. Reddy said.

To see whether changes in disease course or in treatment could explain changes in outcomes for patients with COVID-related ARDS, the investigators compared characteristics and outcomes for patients treated in the first versus second waves of the pandemic. Their study did not include data from patients infected with the Delta variant of the SARS-CoV-2 virus, which became the predominant viral strain later in 2021.

The study included data on 28 patients treated during the first wave, and 13 during the second. The sample included 28 men and 13 women with a mean age of 51 years.

All patients had venovenous ECMO, with cannulation in the femoral or internal jugular veins; some patients received ECMO via a single double-lumen cannula.

There were no significant differences between the two time periods in patient comorbidities prior to initiation of ECMO.

Patients in the second wave were significantly more likely to receive steroids (54% vs. 100%; P = .003) and remdesivir (39% vs. 85%; P = .007). Prone positioning before ECMO was also significantly more frequent in the second wave (11% vs. 85%; P < .001).

Patients in the second wave stayed on ECMO longer – median 20 days versus 14 days for first-wave patients – but as noted before, ECMO mortality rates were significantly higher during the second wave. During the first wave, 33% of patients died while on ECMO, compared with 69% in the second wave (P = .03). Respective 30-day mortality rates were 46% versus 69% (ns).

Rates of complications during ECMO were generally comparable between the groups, including acute renal failure (39% in the first wave vs 38% in the second), sepsis (32% vs. 23%), bacterial pneumonia (11% vs. 8%), and gastrointestinal bleeding (21% vs. 15%). However, significantly more patients in the second wave had cerebral vascular accidents (4% vs. 23%; P = .050).

Senior author Hitoshi Hirose, MD, PhD, professor of surgery at Thomas Jefferson University, said in an interview that the difference in outcomes was likely caused by changes in pre-ECMO therapy between the first and second waves.

“Our study showed the incidence of sepsis had a large impact on the patient outcomes,” he wrote. “We speculate that sepsis was attributed to use of immune modulation therapy. The prevention of the sepsis would be key to improve survival of ECMO for COVID 19.”

“It’s possible that the explanation for this is that patients in the second wave were sicker in a way that wasn’t adequately measured in the first wave,” CHEST 2021 program cochair Christopher Carroll, MD, FCCP, from Connecticut Children’s Medical Center in Hartford, said in an interview.

The differences may also have been attributable to changes in virulence, or to clinical decisions to put sicker patients on ECMO, he said.

Casey Cable, MD, MSc, a pulmonary disease and critical care specialist at Virginia Commonwealth Medical Center in Richmond, also speculated in an interview that second-wave patients may have been sicker.

“One interesting piece of this story is that we now know a lot more – we know about the use of steroids plus or minus remdesivir and proning, and patients received a large majority of those treatments but still got put on ECMO,” she said. “I wonder if there is a subset of really sick patients, and no matter what we treat with – steroids, proning – whatever we do they’re just not going to do well.”

Both Dr. Carroll and Dr. Cable emphasized the importance of ECMO as a rescue therapy for patients with severe, refractory ARDS associated with COVID-19 or other diseases.

Neither Dr. Carroll nor Dr. Cable were involved in the study.

No study funding was reported. Mr. Reddy, Dr. Hirose, Dr. Carroll, and Dr. Cable disclosed no relevant financial relationships.

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

The federal government is stepping up actions to protect Americans from per- and polyfluoroalkyl substances that continue to threaten health through pollution in the air, water, and foods, according to a statement from the White House on Oct. 18.

tupungato/Thinkstock

The comprehensive plan includes efforts to prevent per- and polyfluoroalkyl substances (PFAS) from being released into the air, drinking and ground water, and the food supply chain, according to the statement. Other efforts will expand cleanup and remediation of the impact of PFAS already present in the environment.

PFAS are a category of endocrine-disrupting chemicals (EDCs) that have been used for decades in a range of consumer products including cookware, stain-resistant clothes, fast food wrappers, treatments for carpets and furniture, and firefighting foams. PFAS can be released into the air, and also into surface water, drinking water, and ground water, because of how they are disposed, according to a 2020 report from the Endocrine Society and the International Pollutants Elimination Network. The report suggested that creation of more plastic products will likely increase exposure to PFAS and other EDCs.

The Environmental Protection Agency will take the lead on the Biden administration’s PFAS reduction efforts. The agency announced a PFAS Roadmap, which outlines actions to control PFAS over the next 3 years. The Roadmap’s goals include keeping PFAS out of the environment, holding polluters accountable for their actions, investing in scientific research to learn more about the impact of PFAS on human health, and prioritizing protection for disadvantaged communities. The EPA described its approach to PFAS as three pronged (Research, Restrict, Remediate). Planned actions noted on the EPA website include publication of a national PFAS testing strategy, establishing an improved review process for new PFAS, reviewing existing PFAS, and enhancing reporting to track sources and quantities of PFAS.

White House statement noted that other agencies committed to controlling PFAS include the Department of Defense, which will conduct cleanups and assessments at DOD and National Guard locations; the Food and Drug Administration, which will to expand its food supply testing to estimate dietary exposure to PFAS; and the Department of Agriculture, which is investigating causes and impacts of PFAS in the food system, and supporting research on environmental contaminants including PFAS.

The Department of Homeland Security has conducted an inventory of PFAS use, notably the use of PFAS in firefighting foams, and established an Emerging Contaminants Working Group to remediate PFAS and other contaminants. In addition, the Department of Health & Human Services monitors the evolving science on human health and PFAS and anticipates a report by the Centers for Disease Control and Prevention on the health effects of PFAS exposure, with data from eight states.

The American Chemistry Council (ACC), a trade association for American chemistry companies, issued a statement in response to the EPA’s PFAS Strategic Roadmap in which they supported the value of science-based regulation, but emphasized that PFAS are distinct from one another, and should not be grouped together for regulation purposes.

“According to EPA, approximately 600 PFAS substances are manufactured or in use today, each with its own unique properties and uses, from cellphones to solar panels, for which alternatives are not always available,” according to the ACC statement. “EPA’s Roadmap reinforces the differences between these chemistries and that they should not all be grouped together.” The newly formed Interagency Policy Committee on PFAS will coordinate PFAS response efforts across agencies and “help develop new policy strategies to support research, remediation, and removal of PFAS in communities across the country,” according to the White House statement.

The federal government is stepping up actions to protect Americans from per- and polyfluoroalkyl substances that continue to threaten health through pollution in the air, water, and foods, according to a statement from the White House on Oct. 18.

tupungato/Thinkstock

The comprehensive plan includes efforts to prevent per- and polyfluoroalkyl substances (PFAS) from being released into the air, drinking and ground water, and the food supply chain, according to the statement. Other efforts will expand cleanup and remediation of the impact of PFAS already present in the environment.

PFAS are a category of endocrine-disrupting chemicals (EDCs) that have been used for decades in a range of consumer products including cookware, stain-resistant clothes, fast food wrappers, treatments for carpets and furniture, and firefighting foams. PFAS can be released into the air, and also into surface water, drinking water, and ground water, because of how they are disposed, according to a 2020 report from the Endocrine Society and the International Pollutants Elimination Network. The report suggested that creation of more plastic products will likely increase exposure to PFAS and other EDCs.

The Environmental Protection Agency will take the lead on the Biden administration’s PFAS reduction efforts. The agency announced a PFAS Roadmap, which outlines actions to control PFAS over the next 3 years. The Roadmap’s goals include keeping PFAS out of the environment, holding polluters accountable for their actions, investing in scientific research to learn more about the impact of PFAS on human health, and prioritizing protection for disadvantaged communities. The EPA described its approach to PFAS as three pronged (Research, Restrict, Remediate). Planned actions noted on the EPA website include publication of a national PFAS testing strategy, establishing an improved review process for new PFAS, reviewing existing PFAS, and enhancing reporting to track sources and quantities of PFAS.

White House statement noted that other agencies committed to controlling PFAS include the Department of Defense, which will conduct cleanups and assessments at DOD and National Guard locations; the Food and Drug Administration, which will to expand its food supply testing to estimate dietary exposure to PFAS; and the Department of Agriculture, which is investigating causes and impacts of PFAS in the food system, and supporting research on environmental contaminants including PFAS.

The Department of Homeland Security has conducted an inventory of PFAS use, notably the use of PFAS in firefighting foams, and established an Emerging Contaminants Working Group to remediate PFAS and other contaminants. In addition, the Department of Health & Human Services monitors the evolving science on human health and PFAS and anticipates a report by the Centers for Disease Control and Prevention on the health effects of PFAS exposure, with data from eight states.

The American Chemistry Council (ACC), a trade association for American chemistry companies, issued a statement in response to the EPA’s PFAS Strategic Roadmap in which they supported the value of science-based regulation, but emphasized that PFAS are distinct from one another, and should not be grouped together for regulation purposes.

“According to EPA, approximately 600 PFAS substances are manufactured or in use today, each with its own unique properties and uses, from cellphones to solar panels, for which alternatives are not always available,” according to the ACC statement. “EPA’s Roadmap reinforces the differences between these chemistries and that they should not all be grouped together.” The newly formed Interagency Policy Committee on PFAS will coordinate PFAS response efforts across agencies and “help develop new policy strategies to support research, remediation, and removal of PFAS in communities across the country,” according to the White House statement.

The federal government is stepping up actions to protect Americans from per- and polyfluoroalkyl substances that continue to threaten health through pollution in the air, water, and foods, according to a statement from the White House on Oct. 18.

tupungato/Thinkstock

The comprehensive plan includes efforts to prevent per- and polyfluoroalkyl substances (PFAS) from being released into the air, drinking and ground water, and the food supply chain, according to the statement. Other efforts will expand cleanup and remediation of the impact of PFAS already present in the environment.

PFAS are a category of endocrine-disrupting chemicals (EDCs) that have been used for decades in a range of consumer products including cookware, stain-resistant clothes, fast food wrappers, treatments for carpets and furniture, and firefighting foams. PFAS can be released into the air, and also into surface water, drinking water, and ground water, because of how they are disposed, according to a 2020 report from the Endocrine Society and the International Pollutants Elimination Network. The report suggested that creation of more plastic products will likely increase exposure to PFAS and other EDCs.

The Environmental Protection Agency will take the lead on the Biden administration’s PFAS reduction efforts. The agency announced a PFAS Roadmap, which outlines actions to control PFAS over the next 3 years. The Roadmap’s goals include keeping PFAS out of the environment, holding polluters accountable for their actions, investing in scientific research to learn more about the impact of PFAS on human health, and prioritizing protection for disadvantaged communities. The EPA described its approach to PFAS as three pronged (Research, Restrict, Remediate). Planned actions noted on the EPA website include publication of a national PFAS testing strategy, establishing an improved review process for new PFAS, reviewing existing PFAS, and enhancing reporting to track sources and quantities of PFAS.

White House statement noted that other agencies committed to controlling PFAS include the Department of Defense, which will conduct cleanups and assessments at DOD and National Guard locations; the Food and Drug Administration, which will to expand its food supply testing to estimate dietary exposure to PFAS; and the Department of Agriculture, which is investigating causes and impacts of PFAS in the food system, and supporting research on environmental contaminants including PFAS.

The Department of Homeland Security has conducted an inventory of PFAS use, notably the use of PFAS in firefighting foams, and established an Emerging Contaminants Working Group to remediate PFAS and other contaminants. In addition, the Department of Health & Human Services monitors the evolving science on human health and PFAS and anticipates a report by the Centers for Disease Control and Prevention on the health effects of PFAS exposure, with data from eight states.

The American Chemistry Council (ACC), a trade association for American chemistry companies, issued a statement in response to the EPA’s PFAS Strategic Roadmap in which they supported the value of science-based regulation, but emphasized that PFAS are distinct from one another, and should not be grouped together for regulation purposes.

“According to EPA, approximately 600 PFAS substances are manufactured or in use today, each with its own unique properties and uses, from cellphones to solar panels, for which alternatives are not always available,” according to the ACC statement. “EPA’s Roadmap reinforces the differences between these chemistries and that they should not all be grouped together.” The newly formed Interagency Policy Committee on PFAS will coordinate PFAS response efforts across agencies and “help develop new policy strategies to support research, remediation, and removal of PFAS in communities across the country,” according to the White House statement.

Following up on its 2007 initiative to improve care for people who have ST-segment elevation myocardial infarction (STEMI), the American Heart Association has issued a policy statement that includes a host of recommendations to further overcome barriers to optimal care for this most severe type of heart attack.

American Heart Association

The statement recommends steps for designing what the writing committee calls “the ideal STEMI system of care” for patients who have these severe heart attacks.

The focus of the policy statement is the AHA’s Mission: Lifeline national initiative to coordinate and improve the quality of care to patients with STEMI, which was introduced in 2007. Since then, the number or participating hospitals has increased from 485 to 857, now covering more than 85% of the U.S. population, noted the new statement, published online in Circulation.

“Bringing STEMI referring hospitals, STEMI receiving centers and emergency medical services [EMS] together in the development of local and regional systems of care within the AHA’s Mission: Lifeline program has led to significant improvement in time to treatment and outcomes for patients with STEMI,” Alice K. Jacobs, MD, lead statement author and vice chair for clinical affairs in the department of medicine at Boston Medical Center and a professor at Boston University, said in an interview.

“Yet,” Dr. Jacobs added, “opportunities exist to further improve the coordination of care and address remaining barriers to providing ideal care. Moreover, Mission: Lifeline systems of care have been extended to other time-sensitive cardiovascular disorders including stroke and out-of-hospital cardiac arrest.”

The statement itself noted, “Although there have been significant improvements in patients with STEMI receiving guideline-recommended care, progress has slowed during the past few years.” From 2008 to 2012, a number of key quality care measures at participating hospitals had improved markedly. For example, door-in-door-out (DIDO) transfers improved from a median of 76 to 62 minutes (P < .001).

However, from 2012 to 2019, with more hospitals participating, while many key measures improved, a few either plateaued or worsened slightly. Median DIDO time, for example – again, with more hospitals participating, compared with the earlier dataset – went from 45 in 2012 to 48 in 2019, according to AHA data.

Key recommendations aim to impact and improve hospital care for patients with STEMI, Dr. Jacobs said. “In addition to avoiding patient delay at the onset of recognized symptoms of a heart attack, accessing 911 and following EMS destination protocols, the prehospital activation of the cardiac catheterization lab and providing a 911 response for interhospital transport as well as direct-to-cardiac-catheterization-lab transport bypassing the emergency department when appropriate would all impact and improve hospital care.”

Other key recommendations of the statement include:

• Increasing public awareness of heart attack signs and symptoms and the importance for calling 911.
• Addressing post-MI care, including use of evidence-based practices for cardiac rehabilitation and even getting insurance companies to encourage cardiac rehab through incentives.
• Engaging rural hospitals by leveraging telemedicine to expedite percutaneous coronary intervention (PCI) and by developing systems for treatment protocols and rapid transport among facilities.
• Tearing down financial barriers with a global reimbursement model that encompasses each stop in a patient’s journey through the care system: the referring hospital, receiving center, EMS transport and transfer, and ancillary services.

The statement also took into account improving disparities in the quality of care women with STEMI receive. “It has been reported that women with STEMI may have less typical symptoms than men and arrive later [delay longer] than men after symptom onset,” Dr. Jacobs said. “Educating the public and all members of the health-care team about issues specific to women will be helpful in improving care in women. Of note, STEMI systems of care have been shown to reduce sex and age disparities in care.”

The statement also addressed implications of the COVID-19 pandemic, stating that PCI should remain the dominant treatment for patients with classic STEMI. “Patients must be reassured that appropriate precautions have been implemented by EMS and hospital to protect them and health care workers from COVID-19 infection,” the statement noted.

Dr. Jacobs has no relevant relationships to disclose.

Following up on its 2007 initiative to improve care for people who have ST-segment elevation myocardial infarction (STEMI), the American Heart Association has issued a policy statement that includes a host of recommendations to further overcome barriers to optimal care for this most severe type of heart attack.

American Heart Association

The statement recommends steps for designing what the writing committee calls “the ideal STEMI system of care” for patients who have these severe heart attacks.

The focus of the policy statement is the AHA’s Mission: Lifeline national initiative to coordinate and improve the quality of care to patients with STEMI, which was introduced in 2007. Since then, the number or participating hospitals has increased from 485 to 857, now covering more than 85% of the U.S. population, noted the new statement, published online in Circulation.

“Bringing STEMI referring hospitals, STEMI receiving centers and emergency medical services [EMS] together in the development of local and regional systems of care within the AHA’s Mission: Lifeline program has led to significant improvement in time to treatment and outcomes for patients with STEMI,” Alice K. Jacobs, MD, lead statement author and vice chair for clinical affairs in the department of medicine at Boston Medical Center and a professor at Boston University, said in an interview.

“Yet,” Dr. Jacobs added, “opportunities exist to further improve the coordination of care and address remaining barriers to providing ideal care. Moreover, Mission: Lifeline systems of care have been extended to other time-sensitive cardiovascular disorders including stroke and out-of-hospital cardiac arrest.”

The statement itself noted, “Although there have been significant improvements in patients with STEMI receiving guideline-recommended care, progress has slowed during the past few years.” From 2008 to 2012, a number of key quality care measures at participating hospitals had improved markedly. For example, door-in-door-out (DIDO) transfers improved from a median of 76 to 62 minutes (P < .001).

However, from 2012 to 2019, with more hospitals participating, while many key measures improved, a few either plateaued or worsened slightly. Median DIDO time, for example – again, with more hospitals participating, compared with the earlier dataset – went from 45 in 2012 to 48 in 2019, according to AHA data.

Key recommendations aim to impact and improve hospital care for patients with STEMI, Dr. Jacobs said. “In addition to avoiding patient delay at the onset of recognized symptoms of a heart attack, accessing 911 and following EMS destination protocols, the prehospital activation of the cardiac catheterization lab and providing a 911 response for interhospital transport as well as direct-to-cardiac-catheterization-lab transport bypassing the emergency department when appropriate would all impact and improve hospital care.”

Other key recommendations of the statement include:

• Increasing public awareness of heart attack signs and symptoms and the importance for calling 911.
• Addressing post-MI care, including use of evidence-based practices for cardiac rehabilitation and even getting insurance companies to encourage cardiac rehab through incentives.
• Engaging rural hospitals by leveraging telemedicine to expedite percutaneous coronary intervention (PCI) and by developing systems for treatment protocols and rapid transport among facilities.
• Tearing down financial barriers with a global reimbursement model that encompasses each stop in a patient’s journey through the care system: the referring hospital, receiving center, EMS transport and transfer, and ancillary services.

The statement also took into account improving disparities in the quality of care women with STEMI receive. “It has been reported that women with STEMI may have less typical symptoms than men and arrive later [delay longer] than men after symptom onset,” Dr. Jacobs said. “Educating the public and all members of the health-care team about issues specific to women will be helpful in improving care in women. Of note, STEMI systems of care have been shown to reduce sex and age disparities in care.”

The statement also addressed implications of the COVID-19 pandemic, stating that PCI should remain the dominant treatment for patients with classic STEMI. “Patients must be reassured that appropriate precautions have been implemented by EMS and hospital to protect them and health care workers from COVID-19 infection,” the statement noted.

Dr. Jacobs has no relevant relationships to disclose.

Following up on its 2007 initiative to improve care for people who have ST-segment elevation myocardial infarction (STEMI), the American Heart Association has issued a policy statement that includes a host of recommendations to further overcome barriers to optimal care for this most severe type of heart attack.

American Heart Association

The statement recommends steps for designing what the writing committee calls “the ideal STEMI system of care” for patients who have these severe heart attacks.

The focus of the policy statement is the AHA’s Mission: Lifeline national initiative to coordinate and improve the quality of care to patients with STEMI, which was introduced in 2007. Since then, the number or participating hospitals has increased from 485 to 857, now covering more than 85% of the U.S. population, noted the new statement, published online in Circulation.

“Bringing STEMI referring hospitals, STEMI receiving centers and emergency medical services [EMS] together in the development of local and regional systems of care within the AHA’s Mission: Lifeline program has led to significant improvement in time to treatment and outcomes for patients with STEMI,” Alice K. Jacobs, MD, lead statement author and vice chair for clinical affairs in the department of medicine at Boston Medical Center and a professor at Boston University, said in an interview.

“Yet,” Dr. Jacobs added, “opportunities exist to further improve the coordination of care and address remaining barriers to providing ideal care. Moreover, Mission: Lifeline systems of care have been extended to other time-sensitive cardiovascular disorders including stroke and out-of-hospital cardiac arrest.”

The statement itself noted, “Although there have been significant improvements in patients with STEMI receiving guideline-recommended care, progress has slowed during the past few years.” From 2008 to 2012, a number of key quality care measures at participating hospitals had improved markedly. For example, door-in-door-out (DIDO) transfers improved from a median of 76 to 62 minutes (P < .001).

However, from 2012 to 2019, with more hospitals participating, while many key measures improved, a few either plateaued or worsened slightly. Median DIDO time, for example – again, with more hospitals participating, compared with the earlier dataset – went from 45 in 2012 to 48 in 2019, according to AHA data.

Key recommendations aim to impact and improve hospital care for patients with STEMI, Dr. Jacobs said. “In addition to avoiding patient delay at the onset of recognized symptoms of a heart attack, accessing 911 and following EMS destination protocols, the prehospital activation of the cardiac catheterization lab and providing a 911 response for interhospital transport as well as direct-to-cardiac-catheterization-lab transport bypassing the emergency department when appropriate would all impact and improve hospital care.”

Other key recommendations of the statement include:

• Increasing public awareness of heart attack signs and symptoms and the importance for calling 911.
• Addressing post-MI care, including use of evidence-based practices for cardiac rehabilitation and even getting insurance companies to encourage cardiac rehab through incentives.
• Engaging rural hospitals by leveraging telemedicine to expedite percutaneous coronary intervention (PCI) and by developing systems for treatment protocols and rapid transport among facilities.
• Tearing down financial barriers with a global reimbursement model that encompasses each stop in a patient’s journey through the care system: the referring hospital, receiving center, EMS transport and transfer, and ancillary services.

The statement also took into account improving disparities in the quality of care women with STEMI receive. “It has been reported that women with STEMI may have less typical symptoms than men and arrive later [delay longer] than men after symptom onset,” Dr. Jacobs said. “Educating the public and all members of the health-care team about issues specific to women will be helpful in improving care in women. Of note, STEMI systems of care have been shown to reduce sex and age disparities in care.”

The statement also addressed implications of the COVID-19 pandemic, stating that PCI should remain the dominant treatment for patients with classic STEMI. “Patients must be reassured that appropriate precautions have been implemented by EMS and hospital to protect them and health care workers from COVID-19 infection,” the statement noted.

Dr. Jacobs has no relevant relationships to disclose.

In June, Gerald Bock, MD, a dermatologist in central California, instituted a new office policy: He would not be seeing any more patients who remain unvaccinated against COVID-19 in his practice.

peterschreiber_media/iStock/Getty Images

“[It is] the height of self-centered and irresponsible behavior,” he told me. “People who come in unvaccinated, when vaccination is widely available, are stating that their personal preferences are more important than their health, and are more important than any risk that they may expose their friends and family to, and also to any risk they might present to my staff and me. We have gone to considerable effort and expense to diminish any risk that visiting our office might entail. I see no reason why we should tolerate this.”

Other doctors appear to be following in his footsteps. There is no question that physicians have the right to choose their patients, just as patients are free to choose their doctors, but is it ethical to treat unvaccinated patients differently than their vaccinated counterparts? That is a complicated question without a clear answer. In a statement on whether physicians can decline unvaccinated patients, the American Medical Association continues to maintain that “in general” a physician may not “ethically turn a patient away based solely on the individual’s infectious disease status,” but does concede that “the decision to accept or decline a patient must balance the urgency of the individual patient’s need; the risk the patient may pose to other patients in the physician’s practice; and the need for the physician and staff, to be available to provide care in the future.”

Medical ethics experts have offered varying opinions. Daniel Wikler, PhD, professor of ethics and population health at the Harvard School of Public Health, Boston, wrote in an op-ed in the Washington Post that “ignorance or other personal failing” should not be factors in the evaluation of patients for health care. He argues that “doctors and hospitals are not in the blame and punishment business. Nor should they be. That doctors treat sinners and responsible citizens alike is a noble tradition.”

Timothy Hoff, professor of management, healthcare systems, and health policy at Northeastern University, Boston, maintains that, in nonemergency situations, physicians are legally able to refuse patients for a variety of reasons, provided they are not doing so because of some aspect of the patient’s race, gender, sexuality, or religion. However, in the same Northeastern University news release,Robert Baginski, MD, the director of interdisciplinary affairs for the department of medical sciences at Northeastern, cautions that it is vital for health authorities to continue urging the public to get vaccinated, but not at the expense of care.

Arthur L. Caplan, PhD, the head of the division of medical ethics at New York University, said in a Medscape commentary, that the decision to refuse to see patients who can vaccinate, but choose not to, is justifiable. “If you’re trying to protect yourself, your staff, or other patients, I think you do have the right to not take on somebody who won’t vaccinate,” he writes. “This is somewhat similar to when pediatricians do not accept a family if they won’t give their kids the state-required shots to go to school. That’s been happening for many years now.

“I also think it is morally justified if they won’t take your advice,” he continues. “If they won’t follow what you think is the best healthcare for them [such as getting vaccinated], there’s not much point in building that relationship.”

The situation is different in ED and hospital settings, however. “It’s a little harder to use unvaccinated status when someone really is at death’s door,” Dr. Caplan pointed out. “When someone comes in very sick, or whatever the reason, I think we have to take care of them ethically, and legally we’re bound to get them stable in the emergency room. I do think different rules apply there.”

In the end, every private practitioner will have to make his or her own decision on this question. Dr. Bock feels he made the right one. “Since instituting the policy, we have written 55 refund checks for people who had paid for a series of cosmetic procedures. We have no idea how many people were deterred from making appointments. We’ve had several negative online reviews and one woman who wrote a letter to the Medical Board of California complaining that we were discriminating against her,” he said. He added, however, that “we’ve also had several patients who commented favorably about the policy. I have no regrets about instituting the policy, and would do it again.”

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

In June, Gerald Bock, MD, a dermatologist in central California, instituted a new office policy: He would not be seeing any more patients who remain unvaccinated against COVID-19 in his practice.

peterschreiber_media/iStock/Getty Images

“[It is] the height of self-centered and irresponsible behavior,” he told me. “People who come in unvaccinated, when vaccination is widely available, are stating that their personal preferences are more important than their health, and are more important than any risk that they may expose their friends and family to, and also to any risk they might present to my staff and me. We have gone to considerable effort and expense to diminish any risk that visiting our office might entail. I see no reason why we should tolerate this.”

Other doctors appear to be following in his footsteps. There is no question that physicians have the right to choose their patients, just as patients are free to choose their doctors, but is it ethical to treat unvaccinated patients differently than their vaccinated counterparts? That is a complicated question without a clear answer. In a statement on whether physicians can decline unvaccinated patients, the American Medical Association continues to maintain that “in general” a physician may not “ethically turn a patient away based solely on the individual’s infectious disease status,” but does concede that “the decision to accept or decline a patient must balance the urgency of the individual patient’s need; the risk the patient may pose to other patients in the physician’s practice; and the need for the physician and staff, to be available to provide care in the future.”

Medical ethics experts have offered varying opinions. Daniel Wikler, PhD, professor of ethics and population health at the Harvard School of Public Health, Boston, wrote in an op-ed in the Washington Post that “ignorance or other personal failing” should not be factors in the evaluation of patients for health care. He argues that “doctors and hospitals are not in the blame and punishment business. Nor should they be. That doctors treat sinners and responsible citizens alike is a noble tradition.”

Timothy Hoff, professor of management, healthcare systems, and health policy at Northeastern University, Boston, maintains that, in nonemergency situations, physicians are legally able to refuse patients for a variety of reasons, provided they are not doing so because of some aspect of the patient’s race, gender, sexuality, or religion. However, in the same Northeastern University news release,Robert Baginski, MD, the director of interdisciplinary affairs for the department of medical sciences at Northeastern, cautions that it is vital for health authorities to continue urging the public to get vaccinated, but not at the expense of care.

Arthur L. Caplan, PhD, the head of the division of medical ethics at New York University, said in a Medscape commentary, that the decision to refuse to see patients who can vaccinate, but choose not to, is justifiable. “If you’re trying to protect yourself, your staff, or other patients, I think you do have the right to not take on somebody who won’t vaccinate,” he writes. “This is somewhat similar to when pediatricians do not accept a family if they won’t give their kids the state-required shots to go to school. That’s been happening for many years now.

“I also think it is morally justified if they won’t take your advice,” he continues. “If they won’t follow what you think is the best healthcare for them [such as getting vaccinated], there’s not much point in building that relationship.”

The situation is different in ED and hospital settings, however. “It’s a little harder to use unvaccinated status when someone really is at death’s door,” Dr. Caplan pointed out. “When someone comes in very sick, or whatever the reason, I think we have to take care of them ethically, and legally we’re bound to get them stable in the emergency room. I do think different rules apply there.”

In the end, every private practitioner will have to make his or her own decision on this question. Dr. Bock feels he made the right one. “Since instituting the policy, we have written 55 refund checks for people who had paid for a series of cosmetic procedures. We have no idea how many people were deterred from making appointments. We’ve had several negative online reviews and one woman who wrote a letter to the Medical Board of California complaining that we were discriminating against her,” he said. He added, however, that “we’ve also had several patients who commented favorably about the policy. I have no regrets about instituting the policy, and would do it again.”

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

In June, Gerald Bock, MD, a dermatologist in central California, instituted a new office policy: He would not be seeing any more patients who remain unvaccinated against COVID-19 in his practice.

peterschreiber_media/iStock/Getty Images

“[It is] the height of self-centered and irresponsible behavior,” he told me. “People who come in unvaccinated, when vaccination is widely available, are stating that their personal preferences are more important than their health, and are more important than any risk that they may expose their friends and family to, and also to any risk they might present to my staff and me. We have gone to considerable effort and expense to diminish any risk that visiting our office might entail. I see no reason why we should tolerate this.”

Other doctors appear to be following in his footsteps. There is no question that physicians have the right to choose their patients, just as patients are free to choose their doctors, but is it ethical to treat unvaccinated patients differently than their vaccinated counterparts? That is a complicated question without a clear answer. In a statement on whether physicians can decline unvaccinated patients, the American Medical Association continues to maintain that “in general” a physician may not “ethically turn a patient away based solely on the individual’s infectious disease status,” but does concede that “the decision to accept or decline a patient must balance the urgency of the individual patient’s need; the risk the patient may pose to other patients in the physician’s practice; and the need for the physician and staff, to be available to provide care in the future.”

Medical ethics experts have offered varying opinions. Daniel Wikler, PhD, professor of ethics and population health at the Harvard School of Public Health, Boston, wrote in an op-ed in the Washington Post that “ignorance or other personal failing” should not be factors in the evaluation of patients for health care. He argues that “doctors and hospitals are not in the blame and punishment business. Nor should they be. That doctors treat sinners and responsible citizens alike is a noble tradition.”

Timothy Hoff, professor of management, healthcare systems, and health policy at Northeastern University, Boston, maintains that, in nonemergency situations, physicians are legally able to refuse patients for a variety of reasons, provided they are not doing so because of some aspect of the patient’s race, gender, sexuality, or religion. However, in the same Northeastern University news release,Robert Baginski, MD, the director of interdisciplinary affairs for the department of medical sciences at Northeastern, cautions that it is vital for health authorities to continue urging the public to get vaccinated, but not at the expense of care.

Arthur L. Caplan, PhD, the head of the division of medical ethics at New York University, said in a Medscape commentary, that the decision to refuse to see patients who can vaccinate, but choose not to, is justifiable. “If you’re trying to protect yourself, your staff, or other patients, I think you do have the right to not take on somebody who won’t vaccinate,” he writes. “This is somewhat similar to when pediatricians do not accept a family if they won’t give their kids the state-required shots to go to school. That’s been happening for many years now.

“I also think it is morally justified if they won’t take your advice,” he continues. “If they won’t follow what you think is the best healthcare for them [such as getting vaccinated], there’s not much point in building that relationship.”

The situation is different in ED and hospital settings, however. “It’s a little harder to use unvaccinated status when someone really is at death’s door,” Dr. Caplan pointed out. “When someone comes in very sick, or whatever the reason, I think we have to take care of them ethically, and legally we’re bound to get them stable in the emergency room. I do think different rules apply there.”

In the end, every private practitioner will have to make his or her own decision on this question. Dr. Bock feels he made the right one. “Since instituting the policy, we have written 55 refund checks for people who had paid for a series of cosmetic procedures. We have no idea how many people were deterred from making appointments. We’ve had several negative online reviews and one woman who wrote a letter to the Medical Board of California complaining that we were discriminating against her,” he said. He added, however, that “we’ve also had several patients who commented favorably about the policy. I have no regrets about instituting the policy, and would do it again.”

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

A paper claiming that myocarditis cases spiked after teenagers began receiving COVID-19 vaccines has earned a “temporary removal” — without any explanation from the publisher.

The article, “A Report on Myocarditis Adverse Events in the U.S. Vaccine Adverse Events Reporting System (VAERS) in Association with COVID-19 Injectable Biological Products,” was published in Current Problems in Cardiology, an Elsevier journal, on October 1.

It was co-authored by Jessica Rose and Peter McCullough, whose affiliations are listed as the Public Health Policy Initiative at the Institute of Pure and Applied Knowledge — a group that has been critical of vaccines and of the response to COVID-19 and has funded one study that was retracted earlier this year — and Texas A&M’s Baylor Dallas campus. [See update at the end of the post.]

Last month, Baylor Scott & White obtained a restraining order against McCullough — whom Medscape says “has promoted the use of therapies seen as unproven for the treatment of COVID-19 and has questioned the effectiveness of COVID-19 vaccines” — for continuing to refer to an affiliation with the health care institution despite a separation agreement. “Since the Baylor suit, the Texas A&M College of Medicine, and the Texas Christian University (TCU) and University of North Texas Health Science Center (UNTHSC) School of Medicine have both removed McCullough from their faculties,” Medscape reported at the time.

Here are some highlights of the now temporarily retracted paper’s claims:

Within 8 weeks of the public offering of COVID-19 products to the 12-15-year-old age group, we found 19 times the expected number of myocarditis cases in the vaccination volunteers over background myocarditis rates for this age group. In addition, a 5-fold increase in myocarditis rate was observed subsequent to dose 2 as opposed to dose 1 in 15-year-old males.

While several studies have used the VAERS database and other similar datasets around the world to estimate rates of side effects from COVID-19 vaccines, the approach has been roundly criticized and has led to at least one retraction. VAERS itself includes caution against doing so. (Another paper about myocarditis cases linked to COVID-19 vaccines has been retracted for a serious math error.)

Here’s the notice:

The Publisher regrets that this article has been temporarily removed. A replacement will appear as soon as possible in which the reason for the removal of the article will be specified, or the article will be reinstated.

The full Elsevier Policy on Article Withdrawal can be found at http://www.elsevier.com/locate/withdrawalpolicy .

Rose, the corresponding author of the paper, told Retraction Watch that the publisher had “applied the ‘temporary withdrawal’ label to the paper without informing us.” The publisher, Rose said, “claimed that since ‘it wasn’t an invited paper’ that they were reconsidering publishing it and hence the ‘temporary withdrawal.’”

She said the move was “unheard of” and that Elsevier was “breaching the contract we signed – all fees have been paid for gorgeous color graphics.”

Elsevier has temporarily removed more than 100 papers since 2005, by our count. The papers are often reinstated without any mention of why the paper was removed.

Hector Ventura, the editor of the journal, did not immediately respond to a request for comment.

Update, 10/17/21, 1850 UTC: Rose tells us that the correct affiliations — now noted on the temporarily retracted version — are the Institute of Pure and Applied Knowledge’s Public Health Policy Initiative (PHPI) for her, and the Truth for Health Foundation in Tucson, Ariz. for McCullough. The foundation describes it mission as:

To provide truthful, balanced, medically sound, research-based information and cutting edge updates on prevention and treatment of common medical conditions, including COVID-19 and other infectious diseases, that affect health, quality of life and longevity.

To present faith-based integrated approaches to medical treatment, health and healing services that encompass all dimensions making us human: physical, psychological/emotional, spiritual, social and environmental.

The paper was submitted before McCullough’s departure from Baylor, Rose said.

A version of this article first appeared on Retraction Watch.

A paper claiming that myocarditis cases spiked after teenagers began receiving COVID-19 vaccines has earned a “temporary removal” — without any explanation from the publisher.

The article, “A Report on Myocarditis Adverse Events in the U.S. Vaccine Adverse Events Reporting System (VAERS) in Association with COVID-19 Injectable Biological Products,” was published in Current Problems in Cardiology, an Elsevier journal, on October 1.

It was co-authored by Jessica Rose and Peter McCullough, whose affiliations are listed as the Public Health Policy Initiative at the Institute of Pure and Applied Knowledge — a group that has been critical of vaccines and of the response to COVID-19 and has funded one study that was retracted earlier this year — and Texas A&M’s Baylor Dallas campus. [See update at the end of the post.]

Last month, Baylor Scott & White obtained a restraining order against McCullough — whom Medscape says “has promoted the use of therapies seen as unproven for the treatment of COVID-19 and has questioned the effectiveness of COVID-19 vaccines” — for continuing to refer to an affiliation with the health care institution despite a separation agreement. “Since the Baylor suit, the Texas A&M College of Medicine, and the Texas Christian University (TCU) and University of North Texas Health Science Center (UNTHSC) School of Medicine have both removed McCullough from their faculties,” Medscape reported at the time.

Here are some highlights of the now temporarily retracted paper’s claims:

Within 8 weeks of the public offering of COVID-19 products to the 12-15-year-old age group, we found 19 times the expected number of myocarditis cases in the vaccination volunteers over background myocarditis rates for this age group. In addition, a 5-fold increase in myocarditis rate was observed subsequent to dose 2 as opposed to dose 1 in 15-year-old males.

While several studies have used the VAERS database and other similar datasets around the world to estimate rates of side effects from COVID-19 vaccines, the approach has been roundly criticized and has led to at least one retraction. VAERS itself includes caution against doing so. (Another paper about myocarditis cases linked to COVID-19 vaccines has been retracted for a serious math error.)

Here’s the notice:

The Publisher regrets that this article has been temporarily removed. A replacement will appear as soon as possible in which the reason for the removal of the article will be specified, or the article will be reinstated.

The full Elsevier Policy on Article Withdrawal can be found at http://www.elsevier.com/locate/withdrawalpolicy .

Rose, the corresponding author of the paper, told Retraction Watch that the publisher had “applied the ‘temporary withdrawal’ label to the paper without informing us.” The publisher, Rose said, “claimed that since ‘it wasn’t an invited paper’ that they were reconsidering publishing it and hence the ‘temporary withdrawal.’”

She said the move was “unheard of” and that Elsevier was “breaching the contract we signed – all fees have been paid for gorgeous color graphics.”

Elsevier has temporarily removed more than 100 papers since 2005, by our count. The papers are often reinstated without any mention of why the paper was removed.

Hector Ventura, the editor of the journal, did not immediately respond to a request for comment.

Update, 10/17/21, 1850 UTC: Rose tells us that the correct affiliations — now noted on the temporarily retracted version — are the Institute of Pure and Applied Knowledge’s Public Health Policy Initiative (PHPI) for her, and the Truth for Health Foundation in Tucson, Ariz. for McCullough. The foundation describes it mission as:

To provide truthful, balanced, medically sound, research-based information and cutting edge updates on prevention and treatment of common medical conditions, including COVID-19 and other infectious diseases, that affect health, quality of life and longevity.

To present faith-based integrated approaches to medical treatment, health and healing services that encompass all dimensions making us human: physical, psychological/emotional, spiritual, social and environmental.

The paper was submitted before McCullough’s departure from Baylor, Rose said.

A version of this article first appeared on Retraction Watch.

A paper claiming that myocarditis cases spiked after teenagers began receiving COVID-19 vaccines has earned a “temporary removal” — without any explanation from the publisher.

The article, “A Report on Myocarditis Adverse Events in the U.S. Vaccine Adverse Events Reporting System (VAERS) in Association with COVID-19 Injectable Biological Products,” was published in Current Problems in Cardiology, an Elsevier journal, on October 1.

It was co-authored by Jessica Rose and Peter McCullough, whose affiliations are listed as the Public Health Policy Initiative at the Institute of Pure and Applied Knowledge — a group that has been critical of vaccines and of the response to COVID-19 and has funded one study that was retracted earlier this year — and Texas A&M’s Baylor Dallas campus. [See update at the end of the post.]

Last month, Baylor Scott & White obtained a restraining order against McCullough — whom Medscape says “has promoted the use of therapies seen as unproven for the treatment of COVID-19 and has questioned the effectiveness of COVID-19 vaccines” — for continuing to refer to an affiliation with the health care institution despite a separation agreement. “Since the Baylor suit, the Texas A&M College of Medicine, and the Texas Christian University (TCU) and University of North Texas Health Science Center (UNTHSC) School of Medicine have both removed McCullough from their faculties,” Medscape reported at the time.

Here are some highlights of the now temporarily retracted paper’s claims:

Within 8 weeks of the public offering of COVID-19 products to the 12-15-year-old age group, we found 19 times the expected number of myocarditis cases in the vaccination volunteers over background myocarditis rates for this age group. In addition, a 5-fold increase in myocarditis rate was observed subsequent to dose 2 as opposed to dose 1 in 15-year-old males.

While several studies have used the VAERS database and other similar datasets around the world to estimate rates of side effects from COVID-19 vaccines, the approach has been roundly criticized and has led to at least one retraction. VAERS itself includes caution against doing so. (Another paper about myocarditis cases linked to COVID-19 vaccines has been retracted for a serious math error.)

Here’s the notice:

The Publisher regrets that this article has been temporarily removed. A replacement will appear as soon as possible in which the reason for the removal of the article will be specified, or the article will be reinstated.

The full Elsevier Policy on Article Withdrawal can be found at http://www.elsevier.com/locate/withdrawalpolicy .

Rose, the corresponding author of the paper, told Retraction Watch that the publisher had “applied the ‘temporary withdrawal’ label to the paper without informing us.” The publisher, Rose said, “claimed that since ‘it wasn’t an invited paper’ that they were reconsidering publishing it and hence the ‘temporary withdrawal.’”

She said the move was “unheard of” and that Elsevier was “breaching the contract we signed – all fees have been paid for gorgeous color graphics.”

Elsevier has temporarily removed more than 100 papers since 2005, by our count. The papers are often reinstated without any mention of why the paper was removed.

Hector Ventura, the editor of the journal, did not immediately respond to a request for comment.

Update, 10/17/21, 1850 UTC: Rose tells us that the correct affiliations — now noted on the temporarily retracted version — are the Institute of Pure and Applied Knowledge’s Public Health Policy Initiative (PHPI) for her, and the Truth for Health Foundation in Tucson, Ariz. for McCullough. The foundation describes it mission as:

To provide truthful, balanced, medically sound, research-based information and cutting edge updates on prevention and treatment of common medical conditions, including COVID-19 and other infectious diseases, that affect health, quality of life and longevity.

To present faith-based integrated approaches to medical treatment, health and healing services that encompass all dimensions making us human: physical, psychological/emotional, spiritual, social and environmental.

The paper was submitted before McCullough’s departure from Baylor, Rose said.

A version of this article first appeared on Retraction Watch.

Lupin Pharmaceuticals is recalling all batches of irbesartan tablets USP 75 mg, 150 mg, and 300 mg and irbesartan and hydrochlorothiazide (HCTZ) tablets USP 150 mg/12.5 mg and 300 mg/12.5 mg because of the potential presence of the N-nitrosoirbesartan impurity.

“As part of Lupin’s ongoing assessment, analysis revealed that certain tested active pharmaceutical ingredient (API) batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan,” the company said in a news release posted on the U.S. Food and Drug Administration’s website. It notes that the impurity is a “probable human carcinogen.”

Lupin discontinued the marketing of irbesartan and irbesartan/HCTZ tablets on Jan. 7, 2021. It says it “has received no reports of illness that appear to relate to this issue” and is issuing the recall out of “an abundance of caution.”

The company, however, goes on to note that from Oct. 8, 2018 (the earliest date of shipment from the manufacturing site of any of the affected batches) to September 30 of this year, Lupin received four reports of illness from irbesartan and 0 reports from irbesartan/HCTZ.

Irbesartan is an angiotensin II receptor blocker indicated for treatment of hypertension in patients with type 2 diabetes, elevated serum creatinine, and proteinuria.

Irbesartan/HCTZ tablets include irbesartan and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension in patients not adequately controlled with monotherapy or as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals.

Lupin is notifying wholesalers, distributors, and retail outlets to immediately discontinue sales of the affected product lots and return them to the company. Specific lot numbers can be found here.

The company is advising patients to continue taking their medication and to contact their pharmacist, physician, or health care professional for advice regarding an alternative treatment.

Patients and physicians are also advised to report any adverse events or side effects related to the affected products to MedWatch, the U.S. Food and Drug Administration’s Safety Information and Adverse Event Reporting program.

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

Lupin Pharmaceuticals is recalling all batches of irbesartan tablets USP 75 mg, 150 mg, and 300 mg and irbesartan and hydrochlorothiazide (HCTZ) tablets USP 150 mg/12.5 mg and 300 mg/12.5 mg because of the potential presence of the N-nitrosoirbesartan impurity.

“As part of Lupin’s ongoing assessment, analysis revealed that certain tested active pharmaceutical ingredient (API) batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan,” the company said in a news release posted on the U.S. Food and Drug Administration’s website. It notes that the impurity is a “probable human carcinogen.”

Lupin discontinued the marketing of irbesartan and irbesartan/HCTZ tablets on Jan. 7, 2021. It says it “has received no reports of illness that appear to relate to this issue” and is issuing the recall out of “an abundance of caution.”

The company, however, goes on to note that from Oct. 8, 2018 (the earliest date of shipment from the manufacturing site of any of the affected batches) to September 30 of this year, Lupin received four reports of illness from irbesartan and 0 reports from irbesartan/HCTZ.

Irbesartan is an angiotensin II receptor blocker indicated for treatment of hypertension in patients with type 2 diabetes, elevated serum creatinine, and proteinuria.

Irbesartan/HCTZ tablets include irbesartan and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension in patients not adequately controlled with monotherapy or as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals.

Lupin is notifying wholesalers, distributors, and retail outlets to immediately discontinue sales of the affected product lots and return them to the company. Specific lot numbers can be found here.

The company is advising patients to continue taking their medication and to contact their pharmacist, physician, or health care professional for advice regarding an alternative treatment.

Patients and physicians are also advised to report any adverse events or side effects related to the affected products to MedWatch, the U.S. Food and Drug Administration’s Safety Information and Adverse Event Reporting program.

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

Lupin Pharmaceuticals is recalling all batches of irbesartan tablets USP 75 mg, 150 mg, and 300 mg and irbesartan and hydrochlorothiazide (HCTZ) tablets USP 150 mg/12.5 mg and 300 mg/12.5 mg because of the potential presence of the N-nitrosoirbesartan impurity.

“As part of Lupin’s ongoing assessment, analysis revealed that certain tested active pharmaceutical ingredient (API) batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan,” the company said in a news release posted on the U.S. Food and Drug Administration’s website. It notes that the impurity is a “probable human carcinogen.”

Lupin discontinued the marketing of irbesartan and irbesartan/HCTZ tablets on Jan. 7, 2021. It says it “has received no reports of illness that appear to relate to this issue” and is issuing the recall out of “an abundance of caution.”

The company, however, goes on to note that from Oct. 8, 2018 (the earliest date of shipment from the manufacturing site of any of the affected batches) to September 30 of this year, Lupin received four reports of illness from irbesartan and 0 reports from irbesartan/HCTZ.

Irbesartan is an angiotensin II receptor blocker indicated for treatment of hypertension in patients with type 2 diabetes, elevated serum creatinine, and proteinuria.

Irbesartan/HCTZ tablets include irbesartan and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension in patients not adequately controlled with monotherapy or as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals.

Lupin is notifying wholesalers, distributors, and retail outlets to immediately discontinue sales of the affected product lots and return them to the company. Specific lot numbers can be found here.

The company is advising patients to continue taking their medication and to contact their pharmacist, physician, or health care professional for advice regarding an alternative treatment.

Patients and physicians are also advised to report any adverse events or side effects related to the affected products to MedWatch, the U.S. Food and Drug Administration’s Safety Information and Adverse Event Reporting program.

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