MDedge Endocrinology

Vertex Pharmaceuticals has acquired ViaCyte, bringing together two of the leading biotechnology companies developing stem cell–derived islet cell replacement therapies for type 1 diabetes.

The $320 million cash purchase “will accelerate our goal of transforming, if not curing, type 1 diabetes by expanding our capabilities and bringing additional tools, technologies, and assets to our current stem cell-based programs,” said Vertex Chief Executive Officer and President Reshma Kewalramani, MD, in a company statement.

Last month, Vertex reported on a phase 1/2 multicenter clinical trial for two patients with type 1 diabetes who experienced improved blood glucose control with half doses of the company’s investigational allogeneic stem cell-derived islets (VX-880).

The first person to receive the product remained completely insulin-independent at 9 months post-transplant. A third patient has received the full targeted dose, but the data for this participant have yet to be reported.

For Viacyte’s part, last week the company announced that a clinical hold placed by the U.S. Food and Drug Administration on the trial has been lifted, allowing it to move forward with a planned total enrollment of 17 patients.

“The FDA requested additional information on the program, which we provided expeditiously. We are pleased that the hold has been lifted and look forward to continuing the Phase 1/2 trial in the U.S.,” a Vertex spokesperson told this news organization.

And a company official for ViaCyte presented results for three patients who received pancreatic precursor (PEC-01) cells derived from the company’s proprietary pluripotent stem cell line at the annual meeting of the Endocrine Society held in June. The cells are housed in an open delivery device implanted into a patient’s forearm. All three participants experienced improved blood glucose levels.

That presentation followed ViaCyte’s announcement in February that the first patient with type 1 diabetes had been dosed in a Phase 1 clinical trial of its investigational allogeneic, gene-edited, stem cell-derived product, VCTX210, developed in collaboration with CRISPR Therapeutics’ gene-editing technology. The aim is to generate islet cells that will produce insulin while avoiding recognition by the immune system, thus rendering immunosuppressive drugs unnecessary.

According to Vertex’s announcement, “The acquisition of ViaCyte provides Vertex with complementary assets, capabilities, and technologies, including additional human stem cell lines, intellectual property around stem cell differentiation, and Good Manufacturing Practice ... facilities for cell-based therapies that could accelerate Vertex’s ongoing type 1 diabetes programs. The acquisition also provides access to novel hypoimmune stem cell assets via the ViaCyte collaboration with CRISPR Therapeutics.”

In response to the announcement, the type 1 diabetes advocacy organization JDRF, which has funded the work of both companies, said in a statement that the acquisition “represents a significant stride in cures research for the type 1 diabetes community.”

“The coming together of two leaders in the cell-derived therapies field will undoubtedly accelerate the development of VX-880 by combining their resources, technologies, intellectual property, and more,” it added.

A third company developing stem cell–derived islet cell therapies, Sernova, said in a statement provided to this news organization: “We are very confident that bringing important game-changing technologies together, as we are seeing across the industry, will result in several viable technologies for the millions of people with type 1 diabetes ... We are thrilled that there are several technologies under development using different approaches that have the potential to provide a ‘functional cure’ for this disease.”

Vertex anticipates the acquisition will close later in 2022.

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

Vertex Pharmaceuticals has acquired ViaCyte, bringing together two of the leading biotechnology companies developing stem cell–derived islet cell replacement therapies for type 1 diabetes.

The $320 million cash purchase “will accelerate our goal of transforming, if not curing, type 1 diabetes by expanding our capabilities and bringing additional tools, technologies, and assets to our current stem cell-based programs,” said Vertex Chief Executive Officer and President Reshma Kewalramani, MD, in a company statement.

Last month, Vertex reported on a phase 1/2 multicenter clinical trial for two patients with type 1 diabetes who experienced improved blood glucose control with half doses of the company’s investigational allogeneic stem cell-derived islets (VX-880).

The first person to receive the product remained completely insulin-independent at 9 months post-transplant. A third patient has received the full targeted dose, but the data for this participant have yet to be reported.

For Viacyte’s part, last week the company announced that a clinical hold placed by the U.S. Food and Drug Administration on the trial has been lifted, allowing it to move forward with a planned total enrollment of 17 patients.

“The FDA requested additional information on the program, which we provided expeditiously. We are pleased that the hold has been lifted and look forward to continuing the Phase 1/2 trial in the U.S.,” a Vertex spokesperson told this news organization.

And a company official for ViaCyte presented results for three patients who received pancreatic precursor (PEC-01) cells derived from the company’s proprietary pluripotent stem cell line at the annual meeting of the Endocrine Society held in June. The cells are housed in an open delivery device implanted into a patient’s forearm. All three participants experienced improved blood glucose levels.

That presentation followed ViaCyte’s announcement in February that the first patient with type 1 diabetes had been dosed in a Phase 1 clinical trial of its investigational allogeneic, gene-edited, stem cell-derived product, VCTX210, developed in collaboration with CRISPR Therapeutics’ gene-editing technology. The aim is to generate islet cells that will produce insulin while avoiding recognition by the immune system, thus rendering immunosuppressive drugs unnecessary.

According to Vertex’s announcement, “The acquisition of ViaCyte provides Vertex with complementary assets, capabilities, and technologies, including additional human stem cell lines, intellectual property around stem cell differentiation, and Good Manufacturing Practice ... facilities for cell-based therapies that could accelerate Vertex’s ongoing type 1 diabetes programs. The acquisition also provides access to novel hypoimmune stem cell assets via the ViaCyte collaboration with CRISPR Therapeutics.”

In response to the announcement, the type 1 diabetes advocacy organization JDRF, which has funded the work of both companies, said in a statement that the acquisition “represents a significant stride in cures research for the type 1 diabetes community.”

“The coming together of two leaders in the cell-derived therapies field will undoubtedly accelerate the development of VX-880 by combining their resources, technologies, intellectual property, and more,” it added.

A third company developing stem cell–derived islet cell therapies, Sernova, said in a statement provided to this news organization: “We are very confident that bringing important game-changing technologies together, as we are seeing across the industry, will result in several viable technologies for the millions of people with type 1 diabetes ... We are thrilled that there are several technologies under development using different approaches that have the potential to provide a ‘functional cure’ for this disease.”

Vertex anticipates the acquisition will close later in 2022.

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

Vertex Pharmaceuticals has acquired ViaCyte, bringing together two of the leading biotechnology companies developing stem cell–derived islet cell replacement therapies for type 1 diabetes.

The $320 million cash purchase “will accelerate our goal of transforming, if not curing, type 1 diabetes by expanding our capabilities and bringing additional tools, technologies, and assets to our current stem cell-based programs,” said Vertex Chief Executive Officer and President Reshma Kewalramani, MD, in a company statement.

Last month, Vertex reported on a phase 1/2 multicenter clinical trial for two patients with type 1 diabetes who experienced improved blood glucose control with half doses of the company’s investigational allogeneic stem cell-derived islets (VX-880).

The first person to receive the product remained completely insulin-independent at 9 months post-transplant. A third patient has received the full targeted dose, but the data for this participant have yet to be reported.

For Viacyte’s part, last week the company announced that a clinical hold placed by the U.S. Food and Drug Administration on the trial has been lifted, allowing it to move forward with a planned total enrollment of 17 patients.

“The FDA requested additional information on the program, which we provided expeditiously. We are pleased that the hold has been lifted and look forward to continuing the Phase 1/2 trial in the U.S.,” a Vertex spokesperson told this news organization.

And a company official for ViaCyte presented results for three patients who received pancreatic precursor (PEC-01) cells derived from the company’s proprietary pluripotent stem cell line at the annual meeting of the Endocrine Society held in June. The cells are housed in an open delivery device implanted into a patient’s forearm. All three participants experienced improved blood glucose levels.

That presentation followed ViaCyte’s announcement in February that the first patient with type 1 diabetes had been dosed in a Phase 1 clinical trial of its investigational allogeneic, gene-edited, stem cell-derived product, VCTX210, developed in collaboration with CRISPR Therapeutics’ gene-editing technology. The aim is to generate islet cells that will produce insulin while avoiding recognition by the immune system, thus rendering immunosuppressive drugs unnecessary.

According to Vertex’s announcement, “The acquisition of ViaCyte provides Vertex with complementary assets, capabilities, and technologies, including additional human stem cell lines, intellectual property around stem cell differentiation, and Good Manufacturing Practice ... facilities for cell-based therapies that could accelerate Vertex’s ongoing type 1 diabetes programs. The acquisition also provides access to novel hypoimmune stem cell assets via the ViaCyte collaboration with CRISPR Therapeutics.”

In response to the announcement, the type 1 diabetes advocacy organization JDRF, which has funded the work of both companies, said in a statement that the acquisition “represents a significant stride in cures research for the type 1 diabetes community.”

“The coming together of two leaders in the cell-derived therapies field will undoubtedly accelerate the development of VX-880 by combining their resources, technologies, intellectual property, and more,” it added.

A third company developing stem cell–derived islet cell therapies, Sernova, said in a statement provided to this news organization: “We are very confident that bringing important game-changing technologies together, as we are seeing across the industry, will result in several viable technologies for the millions of people with type 1 diabetes ... We are thrilled that there are several technologies under development using different approaches that have the potential to provide a ‘functional cure’ for this disease.”

Vertex anticipates the acquisition will close later in 2022.

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

Americans could soon have a fourth option for COVID-19 vaccines after the Food and Drug Administration granted emergency use authorization to a two-shot vaccine from Novavax on July 13.

The vaccine is authorized for adults only. Should the Centers for Disease Control and Prevention follow suit and approve its use, Novavax would join Moderna, Pfizer and Johnson & Johnson on the U.S. market. A CDC panel of advisors is expected to consider the new entry on July 19.

The Novavax vaccine is only for those who have not yet been vaccinated at all.

“Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization,” FDA Commissioner Robert Califf, MD, said in a statement. “COVID-19 vaccines remain the best preventive measure against severe disease caused by COVID-19 and I encourage anyone who is eligible for, but has not yet received a COVID-19 vaccine, to consider doing so.”

The Novavax vaccine is protein-based, making it different than mRNA vaccines from Pfizer and Moderna. It contains harmless elements of actual coronavirus spike protein and an ingredient known as a adjuvant that enhances the patient’s immune response.

Clinical trials found the vaccine to be 90.4% effective in preventing mild, moderate or severe COVID-19. Only 17 patients out of 17,200 developed COVID-19 after receiving both doses.

The FDA said, however, that Novavax’s vaccine did show evidence of increased risk of myocarditis – inflammation of the heart – and pericarditis, inflammation of tissue surrounding the heart. In most people both disorders began within 10 days.

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

Americans could soon have a fourth option for COVID-19 vaccines after the Food and Drug Administration granted emergency use authorization to a two-shot vaccine from Novavax on July 13.

The vaccine is authorized for adults only. Should the Centers for Disease Control and Prevention follow suit and approve its use, Novavax would join Moderna, Pfizer and Johnson & Johnson on the U.S. market. A CDC panel of advisors is expected to consider the new entry on July 19.

The Novavax vaccine is only for those who have not yet been vaccinated at all.

“Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization,” FDA Commissioner Robert Califf, MD, said in a statement. “COVID-19 vaccines remain the best preventive measure against severe disease caused by COVID-19 and I encourage anyone who is eligible for, but has not yet received a COVID-19 vaccine, to consider doing so.”

The Novavax vaccine is protein-based, making it different than mRNA vaccines from Pfizer and Moderna. It contains harmless elements of actual coronavirus spike protein and an ingredient known as a adjuvant that enhances the patient’s immune response.

Clinical trials found the vaccine to be 90.4% effective in preventing mild, moderate or severe COVID-19. Only 17 patients out of 17,200 developed COVID-19 after receiving both doses.

The FDA said, however, that Novavax’s vaccine did show evidence of increased risk of myocarditis – inflammation of the heart – and pericarditis, inflammation of tissue surrounding the heart. In most people both disorders began within 10 days.

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

Americans could soon have a fourth option for COVID-19 vaccines after the Food and Drug Administration granted emergency use authorization to a two-shot vaccine from Novavax on July 13.

The vaccine is authorized for adults only. Should the Centers for Disease Control and Prevention follow suit and approve its use, Novavax would join Moderna, Pfizer and Johnson & Johnson on the U.S. market. A CDC panel of advisors is expected to consider the new entry on July 19.

The Novavax vaccine is only for those who have not yet been vaccinated at all.

“Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization,” FDA Commissioner Robert Califf, MD, said in a statement. “COVID-19 vaccines remain the best preventive measure against severe disease caused by COVID-19 and I encourage anyone who is eligible for, but has not yet received a COVID-19 vaccine, to consider doing so.”

The Novavax vaccine is protein-based, making it different than mRNA vaccines from Pfizer and Moderna. It contains harmless elements of actual coronavirus spike protein and an ingredient known as a adjuvant that enhances the patient’s immune response.

Clinical trials found the vaccine to be 90.4% effective in preventing mild, moderate or severe COVID-19. Only 17 patients out of 17,200 developed COVID-19 after receiving both doses.

The FDA said, however, that Novavax’s vaccine did show evidence of increased risk of myocarditis – inflammation of the heart – and pericarditis, inflammation of tissue surrounding the heart. In most people both disorders began within 10 days.

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

Minimizing dietary consumption of simple sugars may help alleviate symptoms of gastroesophageal reflux disease (GERD), new data suggest.

People who consumed lower quantities of simple sugars experienced significant improvement in total acid exposure time, number of reflux episodes, and subjective reports of heartburn and reflux symptoms, compared with those consuming higher amounts of simple sugars, the authors report.

The authors call their study the first randomized controlled diet intervention trial to investigate both the amount and type of carbohydrate on symptomatic GERD and one of only a few to investigate any type of dietary intervention for GERD.

“There’s really almost no rigorous scientific evidence on any of the foods or ingredients or nutrients that are often recommended to avoid if you have GERD,” corresponding author Heidi J. Silver, RD, PhD, told this news organization. Dr. Silver is research professor of medicine at Vanderbilt University School of Medicine and director of the Vanderbilt Diet, Body Composition, and Human Metabolism Core in Nashville, Tenn.

Even the avoidance of fatty foods, which has been long promoted as part of GERD management, has little evidence to support it.

“With fat, there’s some belief that it may slow down gastric emptying. Therefore, if you had slower gastric emptying, you would have a longer time for the food to put pressure on the lower esophageal sphincter and create an environment for reflux. So, it’s kind of conceptually what is thought but not really tested,” she notes.

The findings were published online in the American Journal of Gastroenterology.
 

Greatest symptom reduction with low simple carb intake

To test the role of dietary carbohydrates, Dr. Silver and her colleagues randomly assigned 98 U.S. veterans with symptomatic GERD to intake of one of four diets with varying carbohydrate types and amounts for 9 weeks: high total/high simple (the control group), high total/low simple, low total/high simple, or low total/low simple. The total caloric intake was approximately the same for all groups.

At baseline, the average total carbohydrate consumption was 43.7% of calories, and the average simple sugar intake was 116.5 g/d. The two “low-total” groups averaged about a 10% reduction in carbohydrate calories. The “low-simple” groups reduced simple sugars by about half.

There were no changes in body weight in the control group, whereas all three of the other groups lost some weight, ranging from 1.5-2.0 kg (3.3-4.4 lb) despite calorie totals designed for weight maintenance.

There was a significant effect of diet on the two primary outcomes, total esophageal acid exposure time, and total number of reflux episodes, as measured by 24-hour ambulatory pH monitoring. The change in total acid exposure time was significantly greater for the high total/low simple group, compared with the high total/high simple group.

The participants’ ratings of symptoms assessed by the Gastroesophageal Reflux Disease Questionnaire and the GERD Symptom Assessment Scale, including heartburn frequency and severity, pain in throat/chest, and sleep disturbance, improved in all modified diet groups, compared with the control group. The mean degree of improvement in heartburn and regurgitation was twice as great for the modified diets, compared with the controls, and was greatest for the two “low-simple” carb groups.

Dr. Silver and colleagues hypothesize that the differential effects of the diets may relate to the way that dietary carbohydrates are sensed in the gastrointestinal tract after being enzymatically degraded into monosaccharides, possibly affecting lower esophageal tone via the effects of gut-derived hormones including ghrelin and glucagon-like peptide 1 that are secreted in response to macronutrient intake.

Although more data are needed about the effects of carbohydrates in GERD, Dr. Silver advised, “I do think it would be smart for clinicians, when they’re discussing diet, that they bring up the simple sugars. There’s no potential harm in reducing simple sugars. You’re only benefiting yourself in multiple ways. We know that the consumption of simple sugars is extremely excessive, not just in America but worldwide.”

Asked to comment, Philip O. Katz, MD, professor of medicine and director of the GI Function Laboratories at Weill Cornell Medicine, New York, told this news organization that “this is one of the better-designed studies with a lot of care looking at a lot of endpoints that are intriguing and useful.”

“What it says to me is there is potential for nonpharmacologic interventions for GERD that include diet change for helping patients,” he said. “This shows promise for a diet that doesn’t just concentrate on fat or acidic products and is a possible way of augmenting reflux treatment.”

However, Dr. Katz cautioned, “I don’t think anybody should do more with a 9-week study than look at it as good potential.”

“I would tell patients that this is something that they might try, but I wouldn’t make it a rigid requirement based on these data,” he added. “If I were involved in this study, the next thing I would do is transition it to real life and look at compliance to see if results were sustained at 18 weeks or 6 months.”
 

Diet part of an ‘overall reflux program’

Overall, Dr. Katz, who was the first author of the American College of Gastroenterology’s Clinical Guideline for the Diagnosis and Management of Gastroesophageal Reflux Disease, pointed out that the main nonpharmacologic advice for GERD management includes “Eat smaller meals, don’t eat before bed, don’t lie down after you eat, and reduce any individually known trigger foods.”

Essentially, he views dietary interventions as complementary to medication and other interventions.

“When people really have GERD – not just heartburn – dietary change is an adjunct,” Dr. Katz said. “GERD is a real disease, like diabetes. For some with GERD, maybe this is the only thing they need to do. But, in general, this will be an adjunct to augment an overall reflux program.”

And that program, both Dr. Silver and Dr. Katz said, should include referral to a dietitian or nutritionist.

“If you’re going to invest time in getting your patients to change their diet, it should be done with professional help, a qualified nutritionist who can work with the patient. This should not be a fad,” Dr. Katz said.

Dr. Silver noted, “In contrast to a physician, the dietitian looks at everything the person is eating. If they’re consuming a lot of simple sugars, I certainly would make that recommendation to reduce, along with other recommendations for GERD. It could be easily incorporated. We included examples in the paper of what we did to achieve that reduction and some things clinicians could focus on.”

One obvious approach, she said, is to advise patients to cut the amount of sugared soda they’re drinking, if not eliminate it entirely.

The study was funded by a VA Merit Award. Dr. Silver has no further disclosures. Dr. Katz is a consultant for Phathom Pharmaceuticals and Sebella Pharmaceuticals and serves on an advisory board for AstraZeneca.

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

Minimizing dietary consumption of simple sugars may help alleviate symptoms of gastroesophageal reflux disease (GERD), new data suggest.

People who consumed lower quantities of simple sugars experienced significant improvement in total acid exposure time, number of reflux episodes, and subjective reports of heartburn and reflux symptoms, compared with those consuming higher amounts of simple sugars, the authors report.

The authors call their study the first randomized controlled diet intervention trial to investigate both the amount and type of carbohydrate on symptomatic GERD and one of only a few to investigate any type of dietary intervention for GERD.

“There’s really almost no rigorous scientific evidence on any of the foods or ingredients or nutrients that are often recommended to avoid if you have GERD,” corresponding author Heidi J. Silver, RD, PhD, told this news organization. Dr. Silver is research professor of medicine at Vanderbilt University School of Medicine and director of the Vanderbilt Diet, Body Composition, and Human Metabolism Core in Nashville, Tenn.

Even the avoidance of fatty foods, which has been long promoted as part of GERD management, has little evidence to support it.

“With fat, there’s some belief that it may slow down gastric emptying. Therefore, if you had slower gastric emptying, you would have a longer time for the food to put pressure on the lower esophageal sphincter and create an environment for reflux. So, it’s kind of conceptually what is thought but not really tested,” she notes.

The findings were published online in the American Journal of Gastroenterology.
 

Greatest symptom reduction with low simple carb intake

To test the role of dietary carbohydrates, Dr. Silver and her colleagues randomly assigned 98 U.S. veterans with symptomatic GERD to intake of one of four diets with varying carbohydrate types and amounts for 9 weeks: high total/high simple (the control group), high total/low simple, low total/high simple, or low total/low simple. The total caloric intake was approximately the same for all groups.

At baseline, the average total carbohydrate consumption was 43.7% of calories, and the average simple sugar intake was 116.5 g/d. The two “low-total” groups averaged about a 10% reduction in carbohydrate calories. The “low-simple” groups reduced simple sugars by about half.

There were no changes in body weight in the control group, whereas all three of the other groups lost some weight, ranging from 1.5-2.0 kg (3.3-4.4 lb) despite calorie totals designed for weight maintenance.

There was a significant effect of diet on the two primary outcomes, total esophageal acid exposure time, and total number of reflux episodes, as measured by 24-hour ambulatory pH monitoring. The change in total acid exposure time was significantly greater for the high total/low simple group, compared with the high total/high simple group.

The participants’ ratings of symptoms assessed by the Gastroesophageal Reflux Disease Questionnaire and the GERD Symptom Assessment Scale, including heartburn frequency and severity, pain in throat/chest, and sleep disturbance, improved in all modified diet groups, compared with the control group. The mean degree of improvement in heartburn and regurgitation was twice as great for the modified diets, compared with the controls, and was greatest for the two “low-simple” carb groups.

Dr. Silver and colleagues hypothesize that the differential effects of the diets may relate to the way that dietary carbohydrates are sensed in the gastrointestinal tract after being enzymatically degraded into monosaccharides, possibly affecting lower esophageal tone via the effects of gut-derived hormones including ghrelin and glucagon-like peptide 1 that are secreted in response to macronutrient intake.

Although more data are needed about the effects of carbohydrates in GERD, Dr. Silver advised, “I do think it would be smart for clinicians, when they’re discussing diet, that they bring up the simple sugars. There’s no potential harm in reducing simple sugars. You’re only benefiting yourself in multiple ways. We know that the consumption of simple sugars is extremely excessive, not just in America but worldwide.”

Asked to comment, Philip O. Katz, MD, professor of medicine and director of the GI Function Laboratories at Weill Cornell Medicine, New York, told this news organization that “this is one of the better-designed studies with a lot of care looking at a lot of endpoints that are intriguing and useful.”

“What it says to me is there is potential for nonpharmacologic interventions for GERD that include diet change for helping patients,” he said. “This shows promise for a diet that doesn’t just concentrate on fat or acidic products and is a possible way of augmenting reflux treatment.”

However, Dr. Katz cautioned, “I don’t think anybody should do more with a 9-week study than look at it as good potential.”

“I would tell patients that this is something that they might try, but I wouldn’t make it a rigid requirement based on these data,” he added. “If I were involved in this study, the next thing I would do is transition it to real life and look at compliance to see if results were sustained at 18 weeks or 6 months.”
 

Diet part of an ‘overall reflux program’

Overall, Dr. Katz, who was the first author of the American College of Gastroenterology’s Clinical Guideline for the Diagnosis and Management of Gastroesophageal Reflux Disease, pointed out that the main nonpharmacologic advice for GERD management includes “Eat smaller meals, don’t eat before bed, don’t lie down after you eat, and reduce any individually known trigger foods.”

Essentially, he views dietary interventions as complementary to medication and other interventions.

“When people really have GERD – not just heartburn – dietary change is an adjunct,” Dr. Katz said. “GERD is a real disease, like diabetes. For some with GERD, maybe this is the only thing they need to do. But, in general, this will be an adjunct to augment an overall reflux program.”

And that program, both Dr. Silver and Dr. Katz said, should include referral to a dietitian or nutritionist.

“If you’re going to invest time in getting your patients to change their diet, it should be done with professional help, a qualified nutritionist who can work with the patient. This should not be a fad,” Dr. Katz said.

Dr. Silver noted, “In contrast to a physician, the dietitian looks at everything the person is eating. If they’re consuming a lot of simple sugars, I certainly would make that recommendation to reduce, along with other recommendations for GERD. It could be easily incorporated. We included examples in the paper of what we did to achieve that reduction and some things clinicians could focus on.”

One obvious approach, she said, is to advise patients to cut the amount of sugared soda they’re drinking, if not eliminate it entirely.

The study was funded by a VA Merit Award. Dr. Silver has no further disclosures. Dr. Katz is a consultant for Phathom Pharmaceuticals and Sebella Pharmaceuticals and serves on an advisory board for AstraZeneca.

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

Minimizing dietary consumption of simple sugars may help alleviate symptoms of gastroesophageal reflux disease (GERD), new data suggest.

People who consumed lower quantities of simple sugars experienced significant improvement in total acid exposure time, number of reflux episodes, and subjective reports of heartburn and reflux symptoms, compared with those consuming higher amounts of simple sugars, the authors report.

The authors call their study the first randomized controlled diet intervention trial to investigate both the amount and type of carbohydrate on symptomatic GERD and one of only a few to investigate any type of dietary intervention for GERD.

“There’s really almost no rigorous scientific evidence on any of the foods or ingredients or nutrients that are often recommended to avoid if you have GERD,” corresponding author Heidi J. Silver, RD, PhD, told this news organization. Dr. Silver is research professor of medicine at Vanderbilt University School of Medicine and director of the Vanderbilt Diet, Body Composition, and Human Metabolism Core in Nashville, Tenn.

Even the avoidance of fatty foods, which has been long promoted as part of GERD management, has little evidence to support it.

“With fat, there’s some belief that it may slow down gastric emptying. Therefore, if you had slower gastric emptying, you would have a longer time for the food to put pressure on the lower esophageal sphincter and create an environment for reflux. So, it’s kind of conceptually what is thought but not really tested,” she notes.

The findings were published online in the American Journal of Gastroenterology.
 

Greatest symptom reduction with low simple carb intake

To test the role of dietary carbohydrates, Dr. Silver and her colleagues randomly assigned 98 U.S. veterans with symptomatic GERD to intake of one of four diets with varying carbohydrate types and amounts for 9 weeks: high total/high simple (the control group), high total/low simple, low total/high simple, or low total/low simple. The total caloric intake was approximately the same for all groups.

At baseline, the average total carbohydrate consumption was 43.7% of calories, and the average simple sugar intake was 116.5 g/d. The two “low-total” groups averaged about a 10% reduction in carbohydrate calories. The “low-simple” groups reduced simple sugars by about half.

There were no changes in body weight in the control group, whereas all three of the other groups lost some weight, ranging from 1.5-2.0 kg (3.3-4.4 lb) despite calorie totals designed for weight maintenance.

There was a significant effect of diet on the two primary outcomes, total esophageal acid exposure time, and total number of reflux episodes, as measured by 24-hour ambulatory pH monitoring. The change in total acid exposure time was significantly greater for the high total/low simple group, compared with the high total/high simple group.

The participants’ ratings of symptoms assessed by the Gastroesophageal Reflux Disease Questionnaire and the GERD Symptom Assessment Scale, including heartburn frequency and severity, pain in throat/chest, and sleep disturbance, improved in all modified diet groups, compared with the control group. The mean degree of improvement in heartburn and regurgitation was twice as great for the modified diets, compared with the controls, and was greatest for the two “low-simple” carb groups.

Dr. Silver and colleagues hypothesize that the differential effects of the diets may relate to the way that dietary carbohydrates are sensed in the gastrointestinal tract after being enzymatically degraded into monosaccharides, possibly affecting lower esophageal tone via the effects of gut-derived hormones including ghrelin and glucagon-like peptide 1 that are secreted in response to macronutrient intake.

Although more data are needed about the effects of carbohydrates in GERD, Dr. Silver advised, “I do think it would be smart for clinicians, when they’re discussing diet, that they bring up the simple sugars. There’s no potential harm in reducing simple sugars. You’re only benefiting yourself in multiple ways. We know that the consumption of simple sugars is extremely excessive, not just in America but worldwide.”

Asked to comment, Philip O. Katz, MD, professor of medicine and director of the GI Function Laboratories at Weill Cornell Medicine, New York, told this news organization that “this is one of the better-designed studies with a lot of care looking at a lot of endpoints that are intriguing and useful.”

“What it says to me is there is potential for nonpharmacologic interventions for GERD that include diet change for helping patients,” he said. “This shows promise for a diet that doesn’t just concentrate on fat or acidic products and is a possible way of augmenting reflux treatment.”

However, Dr. Katz cautioned, “I don’t think anybody should do more with a 9-week study than look at it as good potential.”

“I would tell patients that this is something that they might try, but I wouldn’t make it a rigid requirement based on these data,” he added. “If I were involved in this study, the next thing I would do is transition it to real life and look at compliance to see if results were sustained at 18 weeks or 6 months.”
 

Diet part of an ‘overall reflux program’

Overall, Dr. Katz, who was the first author of the American College of Gastroenterology’s Clinical Guideline for the Diagnosis and Management of Gastroesophageal Reflux Disease, pointed out that the main nonpharmacologic advice for GERD management includes “Eat smaller meals, don’t eat before bed, don’t lie down after you eat, and reduce any individually known trigger foods.”

Essentially, he views dietary interventions as complementary to medication and other interventions.

“When people really have GERD – not just heartburn – dietary change is an adjunct,” Dr. Katz said. “GERD is a real disease, like diabetes. For some with GERD, maybe this is the only thing they need to do. But, in general, this will be an adjunct to augment an overall reflux program.”

And that program, both Dr. Silver and Dr. Katz said, should include referral to a dietitian or nutritionist.

“If you’re going to invest time in getting your patients to change their diet, it should be done with professional help, a qualified nutritionist who can work with the patient. This should not be a fad,” Dr. Katz said.

Dr. Silver noted, “In contrast to a physician, the dietitian looks at everything the person is eating. If they’re consuming a lot of simple sugars, I certainly would make that recommendation to reduce, along with other recommendations for GERD. It could be easily incorporated. We included examples in the paper of what we did to achieve that reduction and some things clinicians could focus on.”

One obvious approach, she said, is to advise patients to cut the amount of sugared soda they’re drinking, if not eliminate it entirely.

The study was funded by a VA Merit Award. Dr. Silver has no further disclosures. Dr. Katz is a consultant for Phathom Pharmaceuticals and Sebella Pharmaceuticals and serves on an advisory board for AstraZeneca.

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

Screening children for type 1 diabetes–associated islet autoantibodies at ages 2 years and 6 years would identify most of those who go on to develop the condition by mid-adolescence, new data suggest.

Both genetic screening and islet-cell autoantibody screening for type 1 diabetes risk have become less expensive in recent years. Nonetheless, as of now, most children who receive such screening do so through programs that screen relatives of people who already have the condition, such as the global TrialNet program.

Some in the type 1 diabetes field have urged wider screening, with the rationale that knowledge of increased risk can prepare families to recognize the early signs of hyperglycemia and seek medical help to prevent the onset of diabetic ketoacidosis.

Moreover, potential therapies to prevent or delay type 1 diabetes are currently in development, including the anti-CD3 monoclonal antibody teplizumab (Tzield, Provention Bio).

However, given that the incidence of type 1 diabetes is about 1 in 300 children, any population-wide screening program would need to be implemented in the most efficient and cost-effective way possible with limited numbers of tests, say Mohamed Ghalwash, PhD, of the Center for Computational Health, IBM Research, Yorktown Heights, N.Y., and colleagues.

Results from their analysis of nearly 25,000 children from five prospective cohorts in Europe and the United States were published online  in Lancet Diabetes & Endocrinology.
 

Screening in kids feasible, but may need geographic tweaking

“Our results show that initial screening for islet autoantibodies at two ages (2 years and 6 years) is sensitive and efficient for public health translation but might require adjustment by country on the basis of population-specific disease characteristics,” Dr. Ghalwash and colleagues write.

In an accompanying editorial, pediatric endocrinologist Maria J. Redondo, MD, PhD, writes: “This study is timely because recent successes in preventing type 1 diabetes highlight the need to identify the best candidates for intervention ... This paper constitutes an important contribution to the literature.”

However, Dr. Redondo, of Baylor College of Medicine and Texas Children’s Hospital, Houston, also cautioned: “It remains to be seen whether Dr. Ghalwash and colleagues’ strategy could work in the general population, because all the participants in the combined dataset had genetic risk factors for the disease or a relative with type 1 diabetes, in whom performance is expected to be higher.”

She also noted that most participants were of northern European ancestry and that it is unknown whether the same or a similar screening strategy could be applied to individuals older than 15 years, in whom preclinical type 1 diabetes progresses more slowly.
 

Two-time childhood screening yielded high sensitivity, specificity

The data from a total of 24,662 participants were pooled from five prospective cohorts from Finland (DIPP), Germany (BABYDIAB), Sweden (DiPiS), and the United States (DAISY and DEW-IT).

All were at elevated risk for type 1 diabetes based on human leukocyte antigen (HLA) genotyping, and some had first-degree relatives with the condition. Participants were screened annually for three type 1 diabetes–associated autoantibodies up to age 15 years or the onset of type 1 diabetes.

During follow-up, 672 children developed type 1 diabetes by age 15 years and 6,050 did not. (The rest hadn’t yet reached age 15 years or type 1 diabetes onset.) The median age at first appearance of islet autoantibodies was 4.5 years.

A two-age screening strategy at 2 years and 6 years was more sensitive than screening at just one age, with a sensitivity of 82% and a positive predictive value of 79% for the development of type 1 diabetes by age 15 years.

The predictive value increased with the number of autoantibodies tested. For example, a single islet autoantibody at age 2 years indicated a 4-year risk of developing type 1 diabetes by age 5.99 years of 31%, while multiple antibody positivity at age 2 years carried a 4-year risk of 55%.

By age 6 years, the risk over the next 9 years was 39% if the test had been negative at age 2 years and 70% if the test had been positive at 2 years. But overall, a 6-year-old with multiple autoantibodies had an overall 83% risk of type 1 diabetes regardless of the test result at 2 years.

The predictive performance of sensitivity by age differed by country, suggesting that the optimal ages for autoantibody testing might differ by geographic region, Dr. Ghalwash and colleagues say.

Dr. Redondo commented, “The model might require adaptation to local factors that affect the progression and prevalence of type 1 diabetes.” And, she added, “important aspects, such as screening cost, global access, acceptability, and follow-up support will need to be addressed for this strategy to be a viable public health option.”

The study was funded by JDRF. Dr. Ghalwash and another author are employees of IBM. A third author was a JDRF employee when the research was done and is now an employee of Janssen Research and Development. Dr. Redondo has reported no relevant financial relationships.

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

Screening children for type 1 diabetes–associated islet autoantibodies at ages 2 years and 6 years would identify most of those who go on to develop the condition by mid-adolescence, new data suggest.

Both genetic screening and islet-cell autoantibody screening for type 1 diabetes risk have become less expensive in recent years. Nonetheless, as of now, most children who receive such screening do so through programs that screen relatives of people who already have the condition, such as the global TrialNet program.

Some in the type 1 diabetes field have urged wider screening, with the rationale that knowledge of increased risk can prepare families to recognize the early signs of hyperglycemia and seek medical help to prevent the onset of diabetic ketoacidosis.

Moreover, potential therapies to prevent or delay type 1 diabetes are currently in development, including the anti-CD3 monoclonal antibody teplizumab (Tzield, Provention Bio).

However, given that the incidence of type 1 diabetes is about 1 in 300 children, any population-wide screening program would need to be implemented in the most efficient and cost-effective way possible with limited numbers of tests, say Mohamed Ghalwash, PhD, of the Center for Computational Health, IBM Research, Yorktown Heights, N.Y., and colleagues.

Results from their analysis of nearly 25,000 children from five prospective cohorts in Europe and the United States were published online  in Lancet Diabetes & Endocrinology.
 

Screening in kids feasible, but may need geographic tweaking

“Our results show that initial screening for islet autoantibodies at two ages (2 years and 6 years) is sensitive and efficient for public health translation but might require adjustment by country on the basis of population-specific disease characteristics,” Dr. Ghalwash and colleagues write.

In an accompanying editorial, pediatric endocrinologist Maria J. Redondo, MD, PhD, writes: “This study is timely because recent successes in preventing type 1 diabetes highlight the need to identify the best candidates for intervention ... This paper constitutes an important contribution to the literature.”

However, Dr. Redondo, of Baylor College of Medicine and Texas Children’s Hospital, Houston, also cautioned: “It remains to be seen whether Dr. Ghalwash and colleagues’ strategy could work in the general population, because all the participants in the combined dataset had genetic risk factors for the disease or a relative with type 1 diabetes, in whom performance is expected to be higher.”

She also noted that most participants were of northern European ancestry and that it is unknown whether the same or a similar screening strategy could be applied to individuals older than 15 years, in whom preclinical type 1 diabetes progresses more slowly.
 

Two-time childhood screening yielded high sensitivity, specificity

The data from a total of 24,662 participants were pooled from five prospective cohorts from Finland (DIPP), Germany (BABYDIAB), Sweden (DiPiS), and the United States (DAISY and DEW-IT).

All were at elevated risk for type 1 diabetes based on human leukocyte antigen (HLA) genotyping, and some had first-degree relatives with the condition. Participants were screened annually for three type 1 diabetes–associated autoantibodies up to age 15 years or the onset of type 1 diabetes.

During follow-up, 672 children developed type 1 diabetes by age 15 years and 6,050 did not. (The rest hadn’t yet reached age 15 years or type 1 diabetes onset.) The median age at first appearance of islet autoantibodies was 4.5 years.

A two-age screening strategy at 2 years and 6 years was more sensitive than screening at just one age, with a sensitivity of 82% and a positive predictive value of 79% for the development of type 1 diabetes by age 15 years.

The predictive value increased with the number of autoantibodies tested. For example, a single islet autoantibody at age 2 years indicated a 4-year risk of developing type 1 diabetes by age 5.99 years of 31%, while multiple antibody positivity at age 2 years carried a 4-year risk of 55%.

By age 6 years, the risk over the next 9 years was 39% if the test had been negative at age 2 years and 70% if the test had been positive at 2 years. But overall, a 6-year-old with multiple autoantibodies had an overall 83% risk of type 1 diabetes regardless of the test result at 2 years.

The predictive performance of sensitivity by age differed by country, suggesting that the optimal ages for autoantibody testing might differ by geographic region, Dr. Ghalwash and colleagues say.

Dr. Redondo commented, “The model might require adaptation to local factors that affect the progression and prevalence of type 1 diabetes.” And, she added, “important aspects, such as screening cost, global access, acceptability, and follow-up support will need to be addressed for this strategy to be a viable public health option.”

The study was funded by JDRF. Dr. Ghalwash and another author are employees of IBM. A third author was a JDRF employee when the research was done and is now an employee of Janssen Research and Development. Dr. Redondo has reported no relevant financial relationships.

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

Screening children for type 1 diabetes–associated islet autoantibodies at ages 2 years and 6 years would identify most of those who go on to develop the condition by mid-adolescence, new data suggest.

Both genetic screening and islet-cell autoantibody screening for type 1 diabetes risk have become less expensive in recent years. Nonetheless, as of now, most children who receive such screening do so through programs that screen relatives of people who already have the condition, such as the global TrialNet program.

Some in the type 1 diabetes field have urged wider screening, with the rationale that knowledge of increased risk can prepare families to recognize the early signs of hyperglycemia and seek medical help to prevent the onset of diabetic ketoacidosis.

Moreover, potential therapies to prevent or delay type 1 diabetes are currently in development, including the anti-CD3 monoclonal antibody teplizumab (Tzield, Provention Bio).

However, given that the incidence of type 1 diabetes is about 1 in 300 children, any population-wide screening program would need to be implemented in the most efficient and cost-effective way possible with limited numbers of tests, say Mohamed Ghalwash, PhD, of the Center for Computational Health, IBM Research, Yorktown Heights, N.Y., and colleagues.

Results from their analysis of nearly 25,000 children from five prospective cohorts in Europe and the United States were published online  in Lancet Diabetes & Endocrinology.
 

Screening in kids feasible, but may need geographic tweaking

“Our results show that initial screening for islet autoantibodies at two ages (2 years and 6 years) is sensitive and efficient for public health translation but might require adjustment by country on the basis of population-specific disease characteristics,” Dr. Ghalwash and colleagues write.

In an accompanying editorial, pediatric endocrinologist Maria J. Redondo, MD, PhD, writes: “This study is timely because recent successes in preventing type 1 diabetes highlight the need to identify the best candidates for intervention ... This paper constitutes an important contribution to the literature.”

However, Dr. Redondo, of Baylor College of Medicine and Texas Children’s Hospital, Houston, also cautioned: “It remains to be seen whether Dr. Ghalwash and colleagues’ strategy could work in the general population, because all the participants in the combined dataset had genetic risk factors for the disease or a relative with type 1 diabetes, in whom performance is expected to be higher.”

She also noted that most participants were of northern European ancestry and that it is unknown whether the same or a similar screening strategy could be applied to individuals older than 15 years, in whom preclinical type 1 diabetes progresses more slowly.
 

Two-time childhood screening yielded high sensitivity, specificity

The data from a total of 24,662 participants were pooled from five prospective cohorts from Finland (DIPP), Germany (BABYDIAB), Sweden (DiPiS), and the United States (DAISY and DEW-IT).

All were at elevated risk for type 1 diabetes based on human leukocyte antigen (HLA) genotyping, and some had first-degree relatives with the condition. Participants were screened annually for three type 1 diabetes–associated autoantibodies up to age 15 years or the onset of type 1 diabetes.

During follow-up, 672 children developed type 1 diabetes by age 15 years and 6,050 did not. (The rest hadn’t yet reached age 15 years or type 1 diabetes onset.) The median age at first appearance of islet autoantibodies was 4.5 years.

A two-age screening strategy at 2 years and 6 years was more sensitive than screening at just one age, with a sensitivity of 82% and a positive predictive value of 79% for the development of type 1 diabetes by age 15 years.

The predictive value increased with the number of autoantibodies tested. For example, a single islet autoantibody at age 2 years indicated a 4-year risk of developing type 1 diabetes by age 5.99 years of 31%, while multiple antibody positivity at age 2 years carried a 4-year risk of 55%.

By age 6 years, the risk over the next 9 years was 39% if the test had been negative at age 2 years and 70% if the test had been positive at 2 years. But overall, a 6-year-old with multiple autoantibodies had an overall 83% risk of type 1 diabetes regardless of the test result at 2 years.

The predictive performance of sensitivity by age differed by country, suggesting that the optimal ages for autoantibody testing might differ by geographic region, Dr. Ghalwash and colleagues say.

Dr. Redondo commented, “The model might require adaptation to local factors that affect the progression and prevalence of type 1 diabetes.” And, she added, “important aspects, such as screening cost, global access, acceptability, and follow-up support will need to be addressed for this strategy to be a viable public health option.”

The study was funded by JDRF. Dr. Ghalwash and another author are employees of IBM. A third author was a JDRF employee when the research was done and is now an employee of Janssen Research and Development. Dr. Redondo has reported no relevant financial relationships.

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

Rampant inflation doesn’t just mean a spike in everyday expenses like gas and groceries. It’s also bound to have a significant impact on the cost of health care – and on your practice. A recent report from McKinsey & Company predicts that the current inflationary spiral will force health care providers to charge higher reimbursement rates, and those costs inevitably will be passed along to both employers and consumers. Bottom line: Your patients will likely have to pay more out of pocket.

How, precisely, will inflation affect your practice, and what’s the best way to minimize the damage? Here are seven steps that you, as a physician, can take right now to make the ripple effects of inflation easier for all concerned.
 

Step 1: Maintain operational standards

“Based on the conversations we’ve had with our physician clients that own practices, we see the potential for cost inflation to outrun revenue inflation over the next year,” said Michael Ashley Schulman, CFA, partner and chief investment officer at Running Point Capital, El Segundo, Calif. “Staff wages, as well as office equipment and medical supply costs, are increasing faster than insurance and Medicare/Medicaid reimbursement amounts.” Even so, topflight employees are essential to keep your practice running smoothly. Prioritize excellent nursing. Instead of adding a new hire, compensate your best nurse as well as possible. The same goes for an efficient office manager: On that front, too, you should go the extra mile, even if it means trimming expenses elsewhere.

Step 2: Plan ahead for insurance challenges

Many insurers, including Medicare, set health care costs a year in advance, based on projected growth. This means insurance payouts will stay largely the same for the time being. “Almost all physicians employed by large groups won’t see costs due to inflation rise until next year,” said Mark V. Pauly, PhD, Bendheim Professor in the department of health care management at the University of Pennsylvania, Philadelphia. “For self-employed physicians, there will also be a cushion.”

“The big issue with inflation is that more patients will likely be underinsured,” said Tiffany Johnson, MBA, CFP, co-CEO and financial advisor at Piece of Wealth Planning in Atlanta. “With more out-of-pocket costs ... these patients may not seek out medical treatment or go to see a specialist if they do not believe it is necessary.” A new study from Johns Hopkins found that patients under financial pressure often delay or forgo medical treatment because of food insecurity. Compassionate care is the solution: Direct these patients to financial aid and other resources they may qualify for. That way, they can continue to receive the care they need from you, and your need to pass on costs may be lower.
 

Step 3: Rely on your affiliated health care organization

These are tough times when it comes to expansion. “Since we are in an environment where inflation and interest rates are both high, it will be much harder for physicians to have the capital to invest in new technology to grow or advance their practice,” Ms. Johnson said. With that in mind, keep the lines of communication between you and your affiliated hospital/health care organization more open than ever. Combining practices with another doctor is one way to increase revenue; you might ask if any affiliated doctors are seeking to team up. It’s also vital to attend meetings and pay close attention to budget cuts your organization may be making. And don’t be shy about asking your administrator for profit-boosting recommendations.

Step 4: Revisit vendor relationships

Find out if your vendors will continue to supply you with the goods you need at reasonable rates, and switch now if they won’t. Be proactive. “Test new medical suppliers,” Mr. Schulman advised. “Reread equipment leasing contracts to check if the interest rates have increased. See if buyout, prepay, or refinancing options are more economical. Also, investigate [bringing down] your rental expense by reducing square footage or moving to a lower-cost location.” In light of ongoing supply chain issues, it’s wise to consider alternative products. But stay focused on quality – you don’t want to be stuck with cheap, possibly defective equipment. Spend where it’s essential and cut the fat somewhere else.

Step 5: Don’t waste your assets

Analyze your budget in minute detail. “Now is the time to review your current inventory and overhead costs,” Ms. Johnson said. “Many physicians let their office staff handle the restocking of inventory and office supplies. While this can be efficient for their practice, it also leaves room for unnecessary business expenses.” Take a cold, hard look at your supply closet – what’s in there that you can live without? Don’t reorder it. Then seek out any revenue stream you may be overlooking. “It’s important to review billing to make sure all the services are reimbursable,” Ms. Johnson added. Small mistakes can yield dividends if you find them.

Step 6: Be poised to pivot

Get creative. “To minimize a profit decline, use video consulting – it’s more efficient and less equipment intensive,” Mr. Schulman said. “Look at how remote work and flexible hours can maximize the work your practice accomplishes while cutting office costs.”

Ms. Johnson suggests adding concierge services, noting that “concierge doctors offer personalized care and direct access for an up-front fee.” With this approach, you may see fewer patients, but your payout paperwork will decrease, and that up-front fee can be profitable. Another outside-the-box idea: Start making house calls. A Scripps study found that home health visits requested via app can result in patient care delivered by a doctor and medical assistant in less than 2 hours. House calls can be an effective and profitable solution when it comes to providing nonemergency care and preventive treatment to patients who aren’t mobile, not to mention patients who just appreciate the convenience.
 

Step 7: Maintain transparency

Any economic changes your practice will implement must be communicated to your staff and patients clearly and directly. Keep everyone in the loop and be ready to answer questions immediately. Show those you work with and care for that, regardless of the economy, it’s they who matter to you most. That simple reassurance will prove invaluable.

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

Rampant inflation doesn’t just mean a spike in everyday expenses like gas and groceries. It’s also bound to have a significant impact on the cost of health care – and on your practice. A recent report from McKinsey & Company predicts that the current inflationary spiral will force health care providers to charge higher reimbursement rates, and those costs inevitably will be passed along to both employers and consumers. Bottom line: Your patients will likely have to pay more out of pocket.

How, precisely, will inflation affect your practice, and what’s the best way to minimize the damage? Here are seven steps that you, as a physician, can take right now to make the ripple effects of inflation easier for all concerned.
 

Step 1: Maintain operational standards

“Based on the conversations we’ve had with our physician clients that own practices, we see the potential for cost inflation to outrun revenue inflation over the next year,” said Michael Ashley Schulman, CFA, partner and chief investment officer at Running Point Capital, El Segundo, Calif. “Staff wages, as well as office equipment and medical supply costs, are increasing faster than insurance and Medicare/Medicaid reimbursement amounts.” Even so, topflight employees are essential to keep your practice running smoothly. Prioritize excellent nursing. Instead of adding a new hire, compensate your best nurse as well as possible. The same goes for an efficient office manager: On that front, too, you should go the extra mile, even if it means trimming expenses elsewhere.

Step 2: Plan ahead for insurance challenges

Many insurers, including Medicare, set health care costs a year in advance, based on projected growth. This means insurance payouts will stay largely the same for the time being. “Almost all physicians employed by large groups won’t see costs due to inflation rise until next year,” said Mark V. Pauly, PhD, Bendheim Professor in the department of health care management at the University of Pennsylvania, Philadelphia. “For self-employed physicians, there will also be a cushion.”

“The big issue with inflation is that more patients will likely be underinsured,” said Tiffany Johnson, MBA, CFP, co-CEO and financial advisor at Piece of Wealth Planning in Atlanta. “With more out-of-pocket costs ... these patients may not seek out medical treatment or go to see a specialist if they do not believe it is necessary.” A new study from Johns Hopkins found that patients under financial pressure often delay or forgo medical treatment because of food insecurity. Compassionate care is the solution: Direct these patients to financial aid and other resources they may qualify for. That way, they can continue to receive the care they need from you, and your need to pass on costs may be lower.
 

Step 3: Rely on your affiliated health care organization

These are tough times when it comes to expansion. “Since we are in an environment where inflation and interest rates are both high, it will be much harder for physicians to have the capital to invest in new technology to grow or advance their practice,” Ms. Johnson said. With that in mind, keep the lines of communication between you and your affiliated hospital/health care organization more open than ever. Combining practices with another doctor is one way to increase revenue; you might ask if any affiliated doctors are seeking to team up. It’s also vital to attend meetings and pay close attention to budget cuts your organization may be making. And don’t be shy about asking your administrator for profit-boosting recommendations.

Step 4: Revisit vendor relationships

Find out if your vendors will continue to supply you with the goods you need at reasonable rates, and switch now if they won’t. Be proactive. “Test new medical suppliers,” Mr. Schulman advised. “Reread equipment leasing contracts to check if the interest rates have increased. See if buyout, prepay, or refinancing options are more economical. Also, investigate [bringing down] your rental expense by reducing square footage or moving to a lower-cost location.” In light of ongoing supply chain issues, it’s wise to consider alternative products. But stay focused on quality – you don’t want to be stuck with cheap, possibly defective equipment. Spend where it’s essential and cut the fat somewhere else.

Step 5: Don’t waste your assets

Analyze your budget in minute detail. “Now is the time to review your current inventory and overhead costs,” Ms. Johnson said. “Many physicians let their office staff handle the restocking of inventory and office supplies. While this can be efficient for their practice, it also leaves room for unnecessary business expenses.” Take a cold, hard look at your supply closet – what’s in there that you can live without? Don’t reorder it. Then seek out any revenue stream you may be overlooking. “It’s important to review billing to make sure all the services are reimbursable,” Ms. Johnson added. Small mistakes can yield dividends if you find them.

Step 6: Be poised to pivot

Get creative. “To minimize a profit decline, use video consulting – it’s more efficient and less equipment intensive,” Mr. Schulman said. “Look at how remote work and flexible hours can maximize the work your practice accomplishes while cutting office costs.”

Ms. Johnson suggests adding concierge services, noting that “concierge doctors offer personalized care and direct access for an up-front fee.” With this approach, you may see fewer patients, but your payout paperwork will decrease, and that up-front fee can be profitable. Another outside-the-box idea: Start making house calls. A Scripps study found that home health visits requested via app can result in patient care delivered by a doctor and medical assistant in less than 2 hours. House calls can be an effective and profitable solution when it comes to providing nonemergency care and preventive treatment to patients who aren’t mobile, not to mention patients who just appreciate the convenience.
 

Step 7: Maintain transparency

Any economic changes your practice will implement must be communicated to your staff and patients clearly and directly. Keep everyone in the loop and be ready to answer questions immediately. Show those you work with and care for that, regardless of the economy, it’s they who matter to you most. That simple reassurance will prove invaluable.

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

Rampant inflation doesn’t just mean a spike in everyday expenses like gas and groceries. It’s also bound to have a significant impact on the cost of health care – and on your practice. A recent report from McKinsey & Company predicts that the current inflationary spiral will force health care providers to charge higher reimbursement rates, and those costs inevitably will be passed along to both employers and consumers. Bottom line: Your patients will likely have to pay more out of pocket.

How, precisely, will inflation affect your practice, and what’s the best way to minimize the damage? Here are seven steps that you, as a physician, can take right now to make the ripple effects of inflation easier for all concerned.
 

Step 1: Maintain operational standards

“Based on the conversations we’ve had with our physician clients that own practices, we see the potential for cost inflation to outrun revenue inflation over the next year,” said Michael Ashley Schulman, CFA, partner and chief investment officer at Running Point Capital, El Segundo, Calif. “Staff wages, as well as office equipment and medical supply costs, are increasing faster than insurance and Medicare/Medicaid reimbursement amounts.” Even so, topflight employees are essential to keep your practice running smoothly. Prioritize excellent nursing. Instead of adding a new hire, compensate your best nurse as well as possible. The same goes for an efficient office manager: On that front, too, you should go the extra mile, even if it means trimming expenses elsewhere.

Step 2: Plan ahead for insurance challenges

Many insurers, including Medicare, set health care costs a year in advance, based on projected growth. This means insurance payouts will stay largely the same for the time being. “Almost all physicians employed by large groups won’t see costs due to inflation rise until next year,” said Mark V. Pauly, PhD, Bendheim Professor in the department of health care management at the University of Pennsylvania, Philadelphia. “For self-employed physicians, there will also be a cushion.”

“The big issue with inflation is that more patients will likely be underinsured,” said Tiffany Johnson, MBA, CFP, co-CEO and financial advisor at Piece of Wealth Planning in Atlanta. “With more out-of-pocket costs ... these patients may not seek out medical treatment or go to see a specialist if they do not believe it is necessary.” A new study from Johns Hopkins found that patients under financial pressure often delay or forgo medical treatment because of food insecurity. Compassionate care is the solution: Direct these patients to financial aid and other resources they may qualify for. That way, they can continue to receive the care they need from you, and your need to pass on costs may be lower.
 

Step 3: Rely on your affiliated health care organization

These are tough times when it comes to expansion. “Since we are in an environment where inflation and interest rates are both high, it will be much harder for physicians to have the capital to invest in new technology to grow or advance their practice,” Ms. Johnson said. With that in mind, keep the lines of communication between you and your affiliated hospital/health care organization more open than ever. Combining practices with another doctor is one way to increase revenue; you might ask if any affiliated doctors are seeking to team up. It’s also vital to attend meetings and pay close attention to budget cuts your organization may be making. And don’t be shy about asking your administrator for profit-boosting recommendations.

Step 4: Revisit vendor relationships

Find out if your vendors will continue to supply you with the goods you need at reasonable rates, and switch now if they won’t. Be proactive. “Test new medical suppliers,” Mr. Schulman advised. “Reread equipment leasing contracts to check if the interest rates have increased. See if buyout, prepay, or refinancing options are more economical. Also, investigate [bringing down] your rental expense by reducing square footage or moving to a lower-cost location.” In light of ongoing supply chain issues, it’s wise to consider alternative products. But stay focused on quality – you don’t want to be stuck with cheap, possibly defective equipment. Spend where it’s essential and cut the fat somewhere else.

Step 5: Don’t waste your assets

Analyze your budget in minute detail. “Now is the time to review your current inventory and overhead costs,” Ms. Johnson said. “Many physicians let their office staff handle the restocking of inventory and office supplies. While this can be efficient for their practice, it also leaves room for unnecessary business expenses.” Take a cold, hard look at your supply closet – what’s in there that you can live without? Don’t reorder it. Then seek out any revenue stream you may be overlooking. “It’s important to review billing to make sure all the services are reimbursable,” Ms. Johnson added. Small mistakes can yield dividends if you find them.

Step 6: Be poised to pivot

Get creative. “To minimize a profit decline, use video consulting – it’s more efficient and less equipment intensive,” Mr. Schulman said. “Look at how remote work and flexible hours can maximize the work your practice accomplishes while cutting office costs.”

Ms. Johnson suggests adding concierge services, noting that “concierge doctors offer personalized care and direct access for an up-front fee.” With this approach, you may see fewer patients, but your payout paperwork will decrease, and that up-front fee can be profitable. Another outside-the-box idea: Start making house calls. A Scripps study found that home health visits requested via app can result in patient care delivered by a doctor and medical assistant in less than 2 hours. House calls can be an effective and profitable solution when it comes to providing nonemergency care and preventive treatment to patients who aren’t mobile, not to mention patients who just appreciate the convenience.
 

Step 7: Maintain transparency

Any economic changes your practice will implement must be communicated to your staff and patients clearly and directly. Keep everyone in the loop and be ready to answer questions immediately. Show those you work with and care for that, regardless of the economy, it’s they who matter to you most. That simple reassurance will prove invaluable.

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

The picture around the BA.4 and BA.5 subvariants of Omicron has been really confusing in that the pair is driving up cases but global COVID-19 deaths remain at their lowest level since the beginning of the pandemic. I wanted to explain what is happening with these subvariants, in that the picture seems to be one of antibody evasion without the dodging of cellular immunity. Explaining the two components of the immune response – antibodies versus cellular immune responses – can help us understand where we are in the pandemic and future booster options.

These two subvariants of Omicron, as of July 5, make up more than half of the COVID-19 strains in the United States and are expected to keep increasing. One of two reasons can lead to a variant or subvariant becoming dominant strain: increased transmissibility or evasion of antibodies.

Although BA.4 and BA.5 could be more transmissible than other subvariants of Omicron (which is already very transmissible), this has not yet been established in experiments showing increased affinity for the human receptor or in animal models. What we do know is that BA.4 and BA.5 seem to evade neutralizing antibodies conferred by the vaccines or even prior BA.1 infection (an earlier subvariant of Omicron), which could be the reason we are seeing so many reinfections now. Of note, BA.1 infection conferred antibodies that protected against subsequent BA.2 infection, so we did not see the same spike in cases in the United States with BA.2 (after a large BA.1 spike over the winter) earlier this spring.

Okay, so isn’t evasion of antibodies a bad thing? Of course it is but, luckily, our immune system is “redundant” and doesn›t just rely on antibodies to protect us from infection. In fact, antibodies (such as IgA, which is the mucosal antibody most prevalent in the nose and mouth, and IgG, which is the most prevalent antibody in the bloodstream) are our first line of COVID-19 defense in the nasal mucosa. Therefore, mild upper respiratory infections will be common as BA.4/BA.5 evade our nasal antibodies. Luckily, the rate of severe disease is remaining low throughout the world, probably because of the high amounts of cellular immunity to the virus. B and T cells are our protectors from severe disease.

For instance, two-dose vaccines are still conferring high rates of protection from severe disease with the BA.4 and BA.5 variants, with 87% protection against hospitalization per South Africa data. This is probably attributable to the fact that T-cell immunity from the vaccines remains protective across variants “from Alpha to Omicron,” as described by a recent and elegant paper.

Data from Qatar show that natural infection (even occurring up to 14 months ago) remains very protective (97.3%) against severe disease with the current circulating subvariants, including BA.4 and BA.5. Again, this is probably attributable to T cells which specifically amplify in response to a piece of the virus and help recruit cells to attack the pathogen directly.

The original BA.1 subvariant of Omicron has 26-32 mutations along its spike protein that differ from the “ancestral strain,” and BA.4 and BA.5 variants have a few more. Our T-cell response, even across a mutated spike protein, is so robust that we have not seen Omicron yet able to evade the many T cells (which we produce from the vaccines or infection) that descend upon the mutated virus to fight severe disease. Antibody-producing memory B cells, generated by the vaccines (or prior infection), have been shown to actually adapt their immune response to the variant to which they are exposed.

Therefore, the story of the BA.4 and BA.5 subvariants seems to remain about antibodies vs. cellular immunity. Our immunity in the United States is growing and is from both vaccination and natural infection, with 78.3% of the population having had at least one dose of the vaccine and at least 60% of adults (and 75% of children 0-18) having been exposed to the virus by February 2022, per the Centers for Disease Control and Prevention (with exposure probably much higher now in July 2022 after subsequent Omicron subvariants waves).

So, what about Omicron-specific boosters? A booster shot will just raise antibodies temporarily, but their effectiveness wanes several months later. Moreover, a booster shot against the ancestral strain is not very effective in neutralizing BA.4 and BA.5 (with a prior BA.1 Omicron infection being more effective than a booster). Luckily, Pfizer has promised a BA.4/BA.5-specific mRNA vaccine by October, and Moderna has promised a bivalent vaccine containing BA.4/BA.5 mRNA sequences around the same time. A vaccine that specifically increases antibodies against the most prevalent circulating strain should be important as a booster for those who are predisposed to severe breakthrough infections (for example, those with immunocompromise or older individuals with multiple comorbidities). Moreover, BA.4/BA.5–specific booster vaccines may help prevent mild infections for many individuals. Finally, any booster (or exposure) should diversify and broaden T-cell responses to the virus, and a booster shot will also expand the potency of B cells, making them better able to respond to the newest subvariants as we continue to live with COVID-19.
 

Monica Gandhi, MD, MPH, is an infectious diseases doctor, professor of medicine, and associate chief in the division of HIV, infectious diseases, and global medicine at the University of California, San Francisco.

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

The picture around the BA.4 and BA.5 subvariants of Omicron has been really confusing in that the pair is driving up cases but global COVID-19 deaths remain at their lowest level since the beginning of the pandemic. I wanted to explain what is happening with these subvariants, in that the picture seems to be one of antibody evasion without the dodging of cellular immunity. Explaining the two components of the immune response – antibodies versus cellular immune responses – can help us understand where we are in the pandemic and future booster options.

These two subvariants of Omicron, as of July 5, make up more than half of the COVID-19 strains in the United States and are expected to keep increasing. One of two reasons can lead to a variant or subvariant becoming dominant strain: increased transmissibility or evasion of antibodies.

Although BA.4 and BA.5 could be more transmissible than other subvariants of Omicron (which is already very transmissible), this has not yet been established in experiments showing increased affinity for the human receptor or in animal models. What we do know is that BA.4 and BA.5 seem to evade neutralizing antibodies conferred by the vaccines or even prior BA.1 infection (an earlier subvariant of Omicron), which could be the reason we are seeing so many reinfections now. Of note, BA.1 infection conferred antibodies that protected against subsequent BA.2 infection, so we did not see the same spike in cases in the United States with BA.2 (after a large BA.1 spike over the winter) earlier this spring.

Okay, so isn’t evasion of antibodies a bad thing? Of course it is but, luckily, our immune system is “redundant” and doesn›t just rely on antibodies to protect us from infection. In fact, antibodies (such as IgA, which is the mucosal antibody most prevalent in the nose and mouth, and IgG, which is the most prevalent antibody in the bloodstream) are our first line of COVID-19 defense in the nasal mucosa. Therefore, mild upper respiratory infections will be common as BA.4/BA.5 evade our nasal antibodies. Luckily, the rate of severe disease is remaining low throughout the world, probably because of the high amounts of cellular immunity to the virus. B and T cells are our protectors from severe disease.

For instance, two-dose vaccines are still conferring high rates of protection from severe disease with the BA.4 and BA.5 variants, with 87% protection against hospitalization per South Africa data. This is probably attributable to the fact that T-cell immunity from the vaccines remains protective across variants “from Alpha to Omicron,” as described by a recent and elegant paper.

Data from Qatar show that natural infection (even occurring up to 14 months ago) remains very protective (97.3%) against severe disease with the current circulating subvariants, including BA.4 and BA.5. Again, this is probably attributable to T cells which specifically amplify in response to a piece of the virus and help recruit cells to attack the pathogen directly.

The original BA.1 subvariant of Omicron has 26-32 mutations along its spike protein that differ from the “ancestral strain,” and BA.4 and BA.5 variants have a few more. Our T-cell response, even across a mutated spike protein, is so robust that we have not seen Omicron yet able to evade the many T cells (which we produce from the vaccines or infection) that descend upon the mutated virus to fight severe disease. Antibody-producing memory B cells, generated by the vaccines (or prior infection), have been shown to actually adapt their immune response to the variant to which they are exposed.

Therefore, the story of the BA.4 and BA.5 subvariants seems to remain about antibodies vs. cellular immunity. Our immunity in the United States is growing and is from both vaccination and natural infection, with 78.3% of the population having had at least one dose of the vaccine and at least 60% of adults (and 75% of children 0-18) having been exposed to the virus by February 2022, per the Centers for Disease Control and Prevention (with exposure probably much higher now in July 2022 after subsequent Omicron subvariants waves).

So, what about Omicron-specific boosters? A booster shot will just raise antibodies temporarily, but their effectiveness wanes several months later. Moreover, a booster shot against the ancestral strain is not very effective in neutralizing BA.4 and BA.5 (with a prior BA.1 Omicron infection being more effective than a booster). Luckily, Pfizer has promised a BA.4/BA.5-specific mRNA vaccine by October, and Moderna has promised a bivalent vaccine containing BA.4/BA.5 mRNA sequences around the same time. A vaccine that specifically increases antibodies against the most prevalent circulating strain should be important as a booster for those who are predisposed to severe breakthrough infections (for example, those with immunocompromise or older individuals with multiple comorbidities). Moreover, BA.4/BA.5–specific booster vaccines may help prevent mild infections for many individuals. Finally, any booster (or exposure) should diversify and broaden T-cell responses to the virus, and a booster shot will also expand the potency of B cells, making them better able to respond to the newest subvariants as we continue to live with COVID-19.
 

Monica Gandhi, MD, MPH, is an infectious diseases doctor, professor of medicine, and associate chief in the division of HIV, infectious diseases, and global medicine at the University of California, San Francisco.

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

The picture around the BA.4 and BA.5 subvariants of Omicron has been really confusing in that the pair is driving up cases but global COVID-19 deaths remain at their lowest level since the beginning of the pandemic. I wanted to explain what is happening with these subvariants, in that the picture seems to be one of antibody evasion without the dodging of cellular immunity. Explaining the two components of the immune response – antibodies versus cellular immune responses – can help us understand where we are in the pandemic and future booster options.

These two subvariants of Omicron, as of July 5, make up more than half of the COVID-19 strains in the United States and are expected to keep increasing. One of two reasons can lead to a variant or subvariant becoming dominant strain: increased transmissibility or evasion of antibodies.

Although BA.4 and BA.5 could be more transmissible than other subvariants of Omicron (which is already very transmissible), this has not yet been established in experiments showing increased affinity for the human receptor or in animal models. What we do know is that BA.4 and BA.5 seem to evade neutralizing antibodies conferred by the vaccines or even prior BA.1 infection (an earlier subvariant of Omicron), which could be the reason we are seeing so many reinfections now. Of note, BA.1 infection conferred antibodies that protected against subsequent BA.2 infection, so we did not see the same spike in cases in the United States with BA.2 (after a large BA.1 spike over the winter) earlier this spring.

Okay, so isn’t evasion of antibodies a bad thing? Of course it is but, luckily, our immune system is “redundant” and doesn›t just rely on antibodies to protect us from infection. In fact, antibodies (such as IgA, which is the mucosal antibody most prevalent in the nose and mouth, and IgG, which is the most prevalent antibody in the bloodstream) are our first line of COVID-19 defense in the nasal mucosa. Therefore, mild upper respiratory infections will be common as BA.4/BA.5 evade our nasal antibodies. Luckily, the rate of severe disease is remaining low throughout the world, probably because of the high amounts of cellular immunity to the virus. B and T cells are our protectors from severe disease.

For instance, two-dose vaccines are still conferring high rates of protection from severe disease with the BA.4 and BA.5 variants, with 87% protection against hospitalization per South Africa data. This is probably attributable to the fact that T-cell immunity from the vaccines remains protective across variants “from Alpha to Omicron,” as described by a recent and elegant paper.

Data from Qatar show that natural infection (even occurring up to 14 months ago) remains very protective (97.3%) against severe disease with the current circulating subvariants, including BA.4 and BA.5. Again, this is probably attributable to T cells which specifically amplify in response to a piece of the virus and help recruit cells to attack the pathogen directly.

The original BA.1 subvariant of Omicron has 26-32 mutations along its spike protein that differ from the “ancestral strain,” and BA.4 and BA.5 variants have a few more. Our T-cell response, even across a mutated spike protein, is so robust that we have not seen Omicron yet able to evade the many T cells (which we produce from the vaccines or infection) that descend upon the mutated virus to fight severe disease. Antibody-producing memory B cells, generated by the vaccines (or prior infection), have been shown to actually adapt their immune response to the variant to which they are exposed.

Therefore, the story of the BA.4 and BA.5 subvariants seems to remain about antibodies vs. cellular immunity. Our immunity in the United States is growing and is from both vaccination and natural infection, with 78.3% of the population having had at least one dose of the vaccine and at least 60% of adults (and 75% of children 0-18) having been exposed to the virus by February 2022, per the Centers for Disease Control and Prevention (with exposure probably much higher now in July 2022 after subsequent Omicron subvariants waves).

So, what about Omicron-specific boosters? A booster shot will just raise antibodies temporarily, but their effectiveness wanes several months later. Moreover, a booster shot against the ancestral strain is not very effective in neutralizing BA.4 and BA.5 (with a prior BA.1 Omicron infection being more effective than a booster). Luckily, Pfizer has promised a BA.4/BA.5-specific mRNA vaccine by October, and Moderna has promised a bivalent vaccine containing BA.4/BA.5 mRNA sequences around the same time. A vaccine that specifically increases antibodies against the most prevalent circulating strain should be important as a booster for those who are predisposed to severe breakthrough infections (for example, those with immunocompromise or older individuals with multiple comorbidities). Moreover, BA.4/BA.5–specific booster vaccines may help prevent mild infections for many individuals. Finally, any booster (or exposure) should diversify and broaden T-cell responses to the virus, and a booster shot will also expand the potency of B cells, making them better able to respond to the newest subvariants as we continue to live with COVID-19.
 

Monica Gandhi, MD, MPH, is an infectious diseases doctor, professor of medicine, and associate chief in the division of HIV, infectious diseases, and global medicine at the University of California, San Francisco.

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

Researchers published the study covered in this summary on medRxiv.org as a preprint that has not yet been peer reviewed.

Key takeaways

• The study results suggest that obesity may accelerate waning of antibody response to SARS-CoV-2 vaccination and increased breakthrough infections with COVID-19.
• The findings documented evidence of reduced neutralizing antibody capacity 6 months after primary vaccination in people with severe obesity.
• This was a large study involving about more than 3.5 million people who had received at least two doses of COVID-19 vaccine, including more than 650,000 with obesity.

Why this matters

• Obesity is associated with comorbidities that independently increase the risk for severe COVID-19, including type 2 diabetes, chronic kidney disease, and heart failure.
• The authors concluded that additional or more frequent booster doses are likely to be required to maintain protection among people with obesity against COVID-19.

Study design

• Prospective longitudinal study of the incidence and severity of COVID-19 infections and immune responses in a cohort of more than 3.5 million adults from a Scottish healthcare database who received two or three doses of COVID-19 vaccine. The data came from the study, centered at the University of Edinburgh.
• About 16% had obesity with a body mass index of 30-39.9 kg/m², and an additional 3% had severe obesity with a BMI of 40 or greater.
• Although not specified in this preprint, another said that the vaccines administered in Scotland have been the Pfizer-BioNTech and Oxford-AstraZeneca formulations.

Key results

• Between Sept. 14, 2020, and March 19, 2022, 10,983 people (0.3% of the total cohort; 6.0 events per 1,000 person-years) had severe COVID-19, consisting of 9,733 who were hospitalized and 2,207 who died (957 of those hospitalized also died).
• People with obesity or severe obesity were at higher risk of hospitalization or death from COVID-19 after both a second and third (booster) dose of vaccine.
• Compared with those with normal weight, those with severe obesity (BMI higher than 40) were at significantly increased risk for severe COVID-19 after a second vaccine dose, with an adjusted rate ratio 1.76, whereas those with standard obesity (BMI, 30-40) were at a modestly but significantly increased risk with an adjusted rate ratio of 1.11.
• Breakthrough infections after the second dose for those with severe obesity, obesity, and normal weight occurred on average at 10 weeks, 15 weeks, and 20 weeks, respectively.
• Interaction testing showed that vaccine effectiveness significantly diminished over time across BMI groups, and protection waned more rapidly as BMI increased.
• Results from immunophenotyping studies run in a subgroup of several dozen subjects with severe obesity or normal weight showed significant decrements in the robustness of antibody responses in those with severe obesity 6 months after a second or third vaccine dose.

Limitations

• The authors did not specify any limitations.

Disclosures

• The study received no commercial funding.
• One author received funding from Wellcome.

This is a summary of a preprint research study , “Accelerated waning of the humoral response to SARS-CoV-2 vaccines in obesity,” published by researchers primarily at the University of Cambridge (England), on medRxiv. This study has not yet been peer reviewed. The full text of the study can be found on medRxiv.org.



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

Researchers published the study covered in this summary on medRxiv.org as a preprint that has not yet been peer reviewed.

Key takeaways

• The study results suggest that obesity may accelerate waning of antibody response to SARS-CoV-2 vaccination and increased breakthrough infections with COVID-19.
• The findings documented evidence of reduced neutralizing antibody capacity 6 months after primary vaccination in people with severe obesity.
• This was a large study involving about more than 3.5 million people who had received at least two doses of COVID-19 vaccine, including more than 650,000 with obesity.

Why this matters

• Obesity is associated with comorbidities that independently increase the risk for severe COVID-19, including type 2 diabetes, chronic kidney disease, and heart failure.
• The authors concluded that additional or more frequent booster doses are likely to be required to maintain protection among people with obesity against COVID-19.

Study design

• Prospective longitudinal study of the incidence and severity of COVID-19 infections and immune responses in a cohort of more than 3.5 million adults from a Scottish healthcare database who received two or three doses of COVID-19 vaccine. The data came from the study, centered at the University of Edinburgh.
• About 16% had obesity with a body mass index of 30-39.9 kg/m², and an additional 3% had severe obesity with a BMI of 40 or greater.
• Although not specified in this preprint, another said that the vaccines administered in Scotland have been the Pfizer-BioNTech and Oxford-AstraZeneca formulations.

Key results

• Between Sept. 14, 2020, and March 19, 2022, 10,983 people (0.3% of the total cohort; 6.0 events per 1,000 person-years) had severe COVID-19, consisting of 9,733 who were hospitalized and 2,207 who died (957 of those hospitalized also died).
• People with obesity or severe obesity were at higher risk of hospitalization or death from COVID-19 after both a second and third (booster) dose of vaccine.
• Compared with those with normal weight, those with severe obesity (BMI higher than 40) were at significantly increased risk for severe COVID-19 after a second vaccine dose, with an adjusted rate ratio 1.76, whereas those with standard obesity (BMI, 30-40) were at a modestly but significantly increased risk with an adjusted rate ratio of 1.11.
• Breakthrough infections after the second dose for those with severe obesity, obesity, and normal weight occurred on average at 10 weeks, 15 weeks, and 20 weeks, respectively.
• Interaction testing showed that vaccine effectiveness significantly diminished over time across BMI groups, and protection waned more rapidly as BMI increased.
• Results from immunophenotyping studies run in a subgroup of several dozen subjects with severe obesity or normal weight showed significant decrements in the robustness of antibody responses in those with severe obesity 6 months after a second or third vaccine dose.

Limitations

• The authors did not specify any limitations.

Disclosures

• The study received no commercial funding.
• One author received funding from Wellcome.

This is a summary of a preprint research study , “Accelerated waning of the humoral response to SARS-CoV-2 vaccines in obesity,” published by researchers primarily at the University of Cambridge (England), on medRxiv. This study has not yet been peer reviewed. The full text of the study can be found on medRxiv.org.



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

Researchers published the study covered in this summary on medRxiv.org as a preprint that has not yet been peer reviewed.

Key takeaways

• The study results suggest that obesity may accelerate waning of antibody response to SARS-CoV-2 vaccination and increased breakthrough infections with COVID-19.
• The findings documented evidence of reduced neutralizing antibody capacity 6 months after primary vaccination in people with severe obesity.
• This was a large study involving about more than 3.5 million people who had received at least two doses of COVID-19 vaccine, including more than 650,000 with obesity.

Why this matters

• Obesity is associated with comorbidities that independently increase the risk for severe COVID-19, including type 2 diabetes, chronic kidney disease, and heart failure.
• The authors concluded that additional or more frequent booster doses are likely to be required to maintain protection among people with obesity against COVID-19.

Study design

• Prospective longitudinal study of the incidence and severity of COVID-19 infections and immune responses in a cohort of more than 3.5 million adults from a Scottish healthcare database who received two or three doses of COVID-19 vaccine. The data came from the study, centered at the University of Edinburgh.
• About 16% had obesity with a body mass index of 30-39.9 kg/m², and an additional 3% had severe obesity with a BMI of 40 or greater.
• Although not specified in this preprint, another said that the vaccines administered in Scotland have been the Pfizer-BioNTech and Oxford-AstraZeneca formulations.

Key results

• Between Sept. 14, 2020, and March 19, 2022, 10,983 people (0.3% of the total cohort; 6.0 events per 1,000 person-years) had severe COVID-19, consisting of 9,733 who were hospitalized and 2,207 who died (957 of those hospitalized also died).
• People with obesity or severe obesity were at higher risk of hospitalization or death from COVID-19 after both a second and third (booster) dose of vaccine.
• Compared with those with normal weight, those with severe obesity (BMI higher than 40) were at significantly increased risk for severe COVID-19 after a second vaccine dose, with an adjusted rate ratio 1.76, whereas those with standard obesity (BMI, 30-40) were at a modestly but significantly increased risk with an adjusted rate ratio of 1.11.
• Breakthrough infections after the second dose for those with severe obesity, obesity, and normal weight occurred on average at 10 weeks, 15 weeks, and 20 weeks, respectively.
• Interaction testing showed that vaccine effectiveness significantly diminished over time across BMI groups, and protection waned more rapidly as BMI increased.
• Results from immunophenotyping studies run in a subgroup of several dozen subjects with severe obesity or normal weight showed significant decrements in the robustness of antibody responses in those with severe obesity 6 months after a second or third vaccine dose.

Limitations

• The authors did not specify any limitations.

Disclosures

• The study received no commercial funding.
• One author received funding from Wellcome.

This is a summary of a preprint research study , “Accelerated waning of the humoral response to SARS-CoV-2 vaccines in obesity,” published by researchers primarily at the University of Cambridge (England), on medRxiv. This study has not yet been peer reviewed. The full text of the study can be found on medRxiv.org.



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

A woman wearing purple surgical scrubs stares into a camera, looking frustrated, but doesn’t speak. Superimposed over her head is the text “just realized I only get to Yeet 4 Teets next week,” and a crying emoji. Rain appears to drip down over her while “Stan” by Eminem plays in the background.

That October 2020 TikTok by Sidhbh Gallagher, MD, a Miami-based plastic surgeon known as @gendersurgeon, had almost 10,000 likes and was tagged #topsurgery, #masculoplasty, #ftm, and #transman, among other hashtags.

“What health check do I have to get in preparation for teetus deletus?” is the question in another Dr. Gallagher TikTok. Dr. Gallagher is a prolific user of social media with over 268K TikTok followers and over 44K Instagram followers. Another Dr. Gallagher TikTok account, @thevagicianmd, has some 7K followers.

Another cosmetic surgeon, Tony Mangubat, MD, known as @Tikdoctony to his more than 200K followers, uses similar hashtags – like #teetusdeleetus – in his TikToks.

Clearly not medical terms, hashtags like #yeettheteet and #teetusdeletus are often used by the transgender community. The posts by Dr. Gallagher and Dr. Mangubat are part of an ever-growing wave of social media activity by medical professionals.  

Plastic surgeons have never been shy about advertising their work – and many have taken to social media to do so, including showing before and after photos. A 2020 study published in Plastic and Reconstructive Surgery found that the majority of such surgeons, especially those in private practice, use social media.

But the use of TikTok, Instagram, and other social media platforms by surgeons who specialize in gender reassignment raises questions about the appropriateness of promoting such procedures, especially to a younger-skewing audience.

Because of the limits on pornography and nudity of social media platforms, most social media posts by gender surgeons are about female-to-male (FTM) mastectomies, the fastest-growing transgender procedure.

The American Society of Plastic Surgeons (ASPS) started separately tracking gender-affirmation procedures in 2015. That year, members reported doing 1,360 FTM procedures.

In 2020, the ASPS further separated procedures into additional categories. That year – when many surgeries were postponed because of the COVID-19 pandemic – FTM mastectomies grew by 15%, with 8,548 procedures performed, a far greater number than for any other transgender surgery, and a sixfold increase in the number of procedures done in 2015.
 

‘Gimmicky,’ but building community

Surgeons interviewed for this article said they use social media primarily to connect with patients and to educate in a light-hearted way.

While Dr. Gallagher acknowledges that using #teetusdeletus is “kind of gimmicky,” she said she doesn’t view it as unprofessional because she is “using the words of the community I serve.” Many of her patients have seen a medical professional “who just didn’t understand what it is to have gender dysphoria, didn’t understand what it is to be trans, so going from that experience to somebody who uses the same language as the community uses can be quite a comfortable experience,” she said in an interview.

Dr. Mangubat, a Seattle-area plastic surgeon who has been doing mastectomies for trans male patients since 1988, said he tailors his TikToks to that group. He likes TikTok – which he started using in early 2021 – because it has rules against bullying, swearing, and pornography, he told this news organization.

“It’s really not ... advertising ... it’s a community-building platform,” said Dr. Mangubat. “If you build community, people will trust you, and if you provide good accurate information, then people will be safer,” he said. 

But, “I’m not telling them to come to me,” he stressed.

He always appears in scrubs and doesn’t do music, doesn’t dance, and doesn’t post before and after photos, but he still gets thousands – or sometimes hundreds of thousands – of likes.

His mission, he said, is to answer the community’s questions. “We’re reaching patients that have had their top surgery, that are going to have their top surgery, that are looking for how to get top surgery, that are just starting on testosterone, that haven’t started on testosterone – it’s the whole spectrum of patients,” said Dr. Mangubat.
 

Risks downplayed?

Other surgeons have expressed concern about ethical boundaries and the tendency of social media posts to downplay risks of what are life-changing procedures.

A 2020 study of YouTube videos on top surgery, for instance, concluded that “there were no unbiased videos by board-certified plastic surgeons explaining the risks, benefits, treatment options, and alternatives to surgery.”

Alison Clayton, MBBS, an Australian psychiatrist, said that social media posts can create false expectations because they emphasize style over substance, omit risks, and can create an unwarranted sense of trust in the doctor that can spill over into the physician-patient relationship.

Dr. Clayton also believes that “the gender-affirming surgical procedures being offered to these youth have a scant empirical evidence base for benefits to psychological health and well-being.”

It is known that a number of those who transition, using either opposite sex hormones and/or surgical procedures, later have regret and “detransition,” but statistics are lacking. It is also a controversial area, with many detransitioners saying they didn’t get appropriate care and weren’t properly assessed before being given hormones or heading to surgery.

Most of the gender surgeons interviewed for this article said they see almost “zero” regret if proper mental health evaluations are performed before surgery, and they added, the procedures can relieve dysphoria.

Nevertheless, posts should not be “all fun and games,” said Josef Hadeed, MD, chair of the ASPS Patient Safety Committee and Public Education Committee and a member of its Social Media Subcommittee.

“When someone makes a decision to undergo a surgical procedure, they should be very aware there are some risks and potentially serious risks involved,” he told this news organization.

The ASPS “wants members to use social media in a judicious manner” in a way that educates the public and encourages patients to learn about a procedure and to consult with board-certified plastic surgeons, said Dr. Hadeed.

The Beverly Hills, Calif.–based surgeon does gender-affirmation procedures himself and uses Instagram, on which he has 53.4K followers, to educate patients and highlight his work using before and after photos.

“I like to think I do it in a very tasteful way,” Dr. Hadeed said. “It’s not in a way that’s sort of suggestive to patients, including minors, that this is something they need to get done, because if they are thinking about getting it done there is a lengthy process that they have to go through before they even set foot in our office.”

And he said “it may be inappropriate” to use certain hashtags or terminology, “even if it does ‘speak’ to the patients. Professionally, plastic surgeons should maintain a higher standard and maintain that even with their social media.”

Marci Bowers, MD, a gynecologic surgeon who performs gender-affirming procedures, and who is transgender herself, agreed.

“Some of the posts out there seem sensational, distasteful, and risk compromising patient confidentiality,” Dr. Bowers said in an interview.

“Much of this seemed to cross the line of good taste and appropriateness,” added Dr. Bowers, who is the incoming president of the World Professional Association for Transgender Health (WPATH). “Creating an idealized video without addressing risk is inappropriate and misleading,” she stressed.

“These surgeons would perhaps better serve their clients by focusing on and improving their clinical care,” she added.  

Dr. Bowers said that although WPATH has not addressed social media use in the past, its ethics committee will be taking on the topic this year.

Social media posts about gender-affirming procedures “don’t usually talk about the barriers, they don’t talk about bad outcomes, they tend to just focus on success stories,” said Gwendolyn P. Quinn, MD, a bioethicist, and Livia S. Wan, MD, professor of obstetrics and gynecology at the NYU Grossman School of Medicine.

But she also sees some positives. The posts can help normalize gender-affirming surgery, and post-procedure photos might “help people realize that they can’t just have everything exactly the way they want it to be,” said Dr. Quinn.
 

Does social media influence or educate?

Studies have documented the power of social media to influence desire and decisionmaking, especially when it comes to cosmetic surgery.

“The use of social media creates a vague area between patient confidentiality and entertainment,” writes Nisha Gupta and colleagues of the UCLA David Geffen School of Medicine in a review published in the Aesthetic Surgery Journal.

While social media use is on the rise by plastic surgeons and has the potential to educate, it has also “compromised the integrity of the doctor-patient relationship,” they add.

Surgeons can use tools to place themselves higher in searches, and patients might assume that those who have hundreds of thousands of followers “are the most qualified or trusted, although this is not always the case,” they note.

Markus Rach, PhD, a researcher with the University of Applied Sciences and Arts Northwestern Switzerland, analyzed the impact of TikTok’s plastic surgery content on how adolescents perceived themselves and how it influenced their decision to have a procedure.

Most TikTok users are under age 24, and #plasticsurgery has a huge viewership with some 3.8 billion views at the time of publication, said Dr. Rach. He found that influencers tended to make adolescents feel bad and want surgery but that plastic surgeons had a moderating effect on both negative feelings and the intent to get surgery.

Dr. Bowers said that, despite her concerns, she does not “believe social media influences like TikTok and Facebook create artificial demand.”

However, Dr. Mangubat said social media can make plastic surgery seem enticing. “It can happen, and it does happen,” he said, but he added that’s true for any cosmetic procedure, not just gender-affirming surgery.

The pitfall with social media is that “patients are being sold a vision of themselves that may or may not be possible,” he observed.

Dr. Quinn worries less about people being talked into a procedure and more about those who don’t want surgery.

“There are people who identify as transgender but do not feel the need to change any parts of their body,” she said. “And that should be okay.”
 

Concerns about minors

New guidance from WPATH, their Standards of Care (SOC) 8 – the first update in 10 years – are due to be published this month. As reported by this news organization, and as stated in the draft of the SOC 8 published for comment in December 2021, the organization has recommended lowering the age for “top” surgery from 18 to 15 years.

Dr. Clayton has concerns about young people with gender dysphoria, who she says are “often vulnerable youth, many of whom have comorbid psychiatric and neurodevelopmental disorders.”

“This may contribute to a greater vulnerability of this population to undue influence,” added Dr. Clayton.

Sean Devitt, MD, and Jeffrey M. Kenkel, MD, of the University of Texas Southwestern Medical Center, Dallas, expressed concern that social media posts by plastic surgeons could be especially dangerous for young people.

“Given that the prefrontal cortex, which is largely responsible for impulse control, is not fully developed until the age of 25, is it ethical to allow younger patients to make life-lasting decisions under the guise of education?” they ask in a commentary on the review by Ms. Gupta and colleagues about plastic surgeons’ use of social media. The review did not focus on gender-affirmation procedures.

Many surgeons – but not all – steer clear of genital (“bottom”) surgeries in minors. However, bilateral mastectomies are being performed in those as young as age 13 based on surgeons’ risk-benefit calculus for the patient.

A study, published in May in the Annals of Plastic Surgery, showed there was a 13-fold increase in the number of bilateral mastectomies performed on under-18s between January 2013 and the end of July 2020. Of the 209 minors (age 12-17) who had the surgery, two (0.95%) expressed regret by the time of follow-up, at 3 and 7 years post-operatively, but neither had reversal surgery.

A small 2018 study, published in JAMA Pediatrics, among trans males who had top surgery found high rates of satisfaction, though one of the 68 patients reported experiencing regret “sometimes.” The mean age of patients in the surgical group was 19 years and the youngest patient was 14.

“Most of us who practice heavily in this field will make exceptions, not for genital surgery but typically for top surgery,” said Dr. Gallagher, who added that she operates on one minor [under 18] a month, while doing some 400-500 gender-affirmative surgeries a year. For some patients, “doing nothing isn’t necessarily a no-harm option,” said Dr. Gallagher.

“Arbitrarily picking the age of 18 and sentencing that patient to another year of dysphoria” might not be the best risk-benefit calculus, she said.  

Dr. Mangubat agrees, especially if, for example, a trans man develops double D breasts by age 14. “You’ve sentenced them to 4 years of misery” before they can get insurance coverage, he said. His youngest top surgery patient was age 15. He said the person’s family, mental health professional, and primary care physician were all in favor of the procedure.

Dr. Mangubat also noted that some insurers, such as Kaiser Permanente, now cover bilateral mastectomy starting at age 16.

Dr. Quinn, the bioethicist, said not every minor or young adult is equipped to make the best long-term decisions.

She works with younger patients who have cancer, for example, and said her suggestions that they consider fertility preservation are often met with protestations “that they will never have children.”

The same issue arises with transgender patients. They may not want to think about having children or issues such as breast feeding while in their teens or early 20s. “But you know from your experience that they may feel differently in 10 years, but they’re just not in the mind frame to think about it,” said Dr. Quinn.

Some young people may accurately never want children, said Dr. Quinn, “but there is a lack of maturity shown when a person just shuts down a conversation and won’t even listen to infertility threats and potential preservation options.”  
 

Concerns about regret?

Dr. Gallagher said she follows the WPATH standards, which require mental health evaluations, and as a result, “the risk of regret is incredibly low.”

However, one of Dr. Gallagher’s patients who detransitioned, Grace, who goes by @HormoneHangover on social media, said she has taken umbrage at some of the Miami surgeon’s TikToks, including one, “Why might some patients feel sad after surgery ... despite wanting it for so long??”

“This is actually not uncommon with ANY kind of surgery, but it’s temporary!” said the TikTok text. Dr. Gallagher is wearing a red dress and heels and flips her hair while the text scrolls above her.

But to Grace, the TikTok “really bothered me, because sometimes there is regret, and I think that sort of advertising paints a falsely rosy picture,” she said in an interview.

And it is emblematic of what she feels was Dr. Gallagher’s “breezy” approach to explaining the procedure to her. “The surgery itself was a shocking experience for me,” she said. “The physical experience was very jarring. It was very disturbing in a way I hadn’t anticipated or understood in advance,” said Grace.

Dr. Mangubat, who does 100 bilateral mastectomies in trans patients a year, said he goes to great lengths to ensure his patients are good candidates. Everyone – even those who self-pay – must have counseling, and if the individual seems to be considering the surgery because it’s “trendy,” he steers clear.

“If they’re not serious about it, I don’t want to operate on them,” said Dr. Mangubat. “There have been maybe two patients who have come back” to detransition, he said. 

Dr. Hadeed also said he has not seen regret. He attributes this to his vetting process, which includes investigating the background of the mental health professionals who write support letters.

“We’ve turned away a lot of patients from our office either because of inadequate letters or because the person writing the letter just doesn’t really have any proper credentials,” he said.
 

Is social media use by plastic surgeons the new normal?

With so many plastic surgeons – including those who perform transgender procedures – using social media, it may increasingly be just part of doing business.

“Undoubtedly gender surgery teams will have a greater presence on social media in the future,” write Alireza Hamidian Jahromi, MD, and a colleague of the plastic surgery department at Rush University Medical Center, Chicago, in a letter published in Plastic and Reconstructive Surgery.  

Kyle R. Latack, MD, and colleagues at the University of Southern California and the University of Michigan, have studied the use of social media by the transgender community and write that they believe “there should be an increased effort to develop high-quality and unbiased resources for patient education that can be made [available] on social media.”

Dr. Gallagher said TikTok helped her erase fear. “A bilateral mastectomy is a scary surgery for an 18-year-old or a 20-year-old,” she said, “but they have to do it for their well-being.”

“That is a criticism I’ve heard – that I seek to minimize it or that I’m flippant about it,” said Dr. Gallagher.

For “top surgery the risk profile is pretty low,” she said, “so what I try to do is educate people that it’s maybe not as scary a procedure as they think.”

Dr. Mangubat, however, is concerned about some of what he sees, especially the explosion of surgeons offering gender-affirming procedures. “Now everybody wants a piece of it,” he said.

“Let’s face it, it’s money now. You get paid for doing this surgery. Hospitals get paid a lot of money for their operating rooms for doing the surgery,” said Dr. Mangubat. “There are some surgeons who believe the transgender community is just another market.”

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

A woman wearing purple surgical scrubs stares into a camera, looking frustrated, but doesn’t speak. Superimposed over her head is the text “just realized I only get to Yeet 4 Teets next week,” and a crying emoji. Rain appears to drip down over her while “Stan” by Eminem plays in the background.

That October 2020 TikTok by Sidhbh Gallagher, MD, a Miami-based plastic surgeon known as @gendersurgeon, had almost 10,000 likes and was tagged #topsurgery, #masculoplasty, #ftm, and #transman, among other hashtags.

“What health check do I have to get in preparation for teetus deletus?” is the question in another Dr. Gallagher TikTok. Dr. Gallagher is a prolific user of social media with over 268K TikTok followers and over 44K Instagram followers. Another Dr. Gallagher TikTok account, @thevagicianmd, has some 7K followers.

Another cosmetic surgeon, Tony Mangubat, MD, known as @Tikdoctony to his more than 200K followers, uses similar hashtags – like #teetusdeleetus – in his TikToks.

Clearly not medical terms, hashtags like #yeettheteet and #teetusdeletus are often used by the transgender community. The posts by Dr. Gallagher and Dr. Mangubat are part of an ever-growing wave of social media activity by medical professionals.  

Plastic surgeons have never been shy about advertising their work – and many have taken to social media to do so, including showing before and after photos. A 2020 study published in Plastic and Reconstructive Surgery found that the majority of such surgeons, especially those in private practice, use social media.

But the use of TikTok, Instagram, and other social media platforms by surgeons who specialize in gender reassignment raises questions about the appropriateness of promoting such procedures, especially to a younger-skewing audience.

Because of the limits on pornography and nudity of social media platforms, most social media posts by gender surgeons are about female-to-male (FTM) mastectomies, the fastest-growing transgender procedure.

The American Society of Plastic Surgeons (ASPS) started separately tracking gender-affirmation procedures in 2015. That year, members reported doing 1,360 FTM procedures.

In 2020, the ASPS further separated procedures into additional categories. That year – when many surgeries were postponed because of the COVID-19 pandemic – FTM mastectomies grew by 15%, with 8,548 procedures performed, a far greater number than for any other transgender surgery, and a sixfold increase in the number of procedures done in 2015.
 

‘Gimmicky,’ but building community

Surgeons interviewed for this article said they use social media primarily to connect with patients and to educate in a light-hearted way.

While Dr. Gallagher acknowledges that using #teetusdeletus is “kind of gimmicky,” she said she doesn’t view it as unprofessional because she is “using the words of the community I serve.” Many of her patients have seen a medical professional “who just didn’t understand what it is to have gender dysphoria, didn’t understand what it is to be trans, so going from that experience to somebody who uses the same language as the community uses can be quite a comfortable experience,” she said in an interview.

Dr. Mangubat, a Seattle-area plastic surgeon who has been doing mastectomies for trans male patients since 1988, said he tailors his TikToks to that group. He likes TikTok – which he started using in early 2021 – because it has rules against bullying, swearing, and pornography, he told this news organization.

“It’s really not ... advertising ... it’s a community-building platform,” said Dr. Mangubat. “If you build community, people will trust you, and if you provide good accurate information, then people will be safer,” he said. 

But, “I’m not telling them to come to me,” he stressed.

He always appears in scrubs and doesn’t do music, doesn’t dance, and doesn’t post before and after photos, but he still gets thousands – or sometimes hundreds of thousands – of likes.

His mission, he said, is to answer the community’s questions. “We’re reaching patients that have had their top surgery, that are going to have their top surgery, that are looking for how to get top surgery, that are just starting on testosterone, that haven’t started on testosterone – it’s the whole spectrum of patients,” said Dr. Mangubat.
 

Risks downplayed?

Other surgeons have expressed concern about ethical boundaries and the tendency of social media posts to downplay risks of what are life-changing procedures.

A 2020 study of YouTube videos on top surgery, for instance, concluded that “there were no unbiased videos by board-certified plastic surgeons explaining the risks, benefits, treatment options, and alternatives to surgery.”

Alison Clayton, MBBS, an Australian psychiatrist, said that social media posts can create false expectations because they emphasize style over substance, omit risks, and can create an unwarranted sense of trust in the doctor that can spill over into the physician-patient relationship.

Dr. Clayton also believes that “the gender-affirming surgical procedures being offered to these youth have a scant empirical evidence base for benefits to psychological health and well-being.”

It is known that a number of those who transition, using either opposite sex hormones and/or surgical procedures, later have regret and “detransition,” but statistics are lacking. It is also a controversial area, with many detransitioners saying they didn’t get appropriate care and weren’t properly assessed before being given hormones or heading to surgery.

Most of the gender surgeons interviewed for this article said they see almost “zero” regret if proper mental health evaluations are performed before surgery, and they added, the procedures can relieve dysphoria.

Nevertheless, posts should not be “all fun and games,” said Josef Hadeed, MD, chair of the ASPS Patient Safety Committee and Public Education Committee and a member of its Social Media Subcommittee.

“When someone makes a decision to undergo a surgical procedure, they should be very aware there are some risks and potentially serious risks involved,” he told this news organization.

The ASPS “wants members to use social media in a judicious manner” in a way that educates the public and encourages patients to learn about a procedure and to consult with board-certified plastic surgeons, said Dr. Hadeed.

The Beverly Hills, Calif.–based surgeon does gender-affirmation procedures himself and uses Instagram, on which he has 53.4K followers, to educate patients and highlight his work using before and after photos.

“I like to think I do it in a very tasteful way,” Dr. Hadeed said. “It’s not in a way that’s sort of suggestive to patients, including minors, that this is something they need to get done, because if they are thinking about getting it done there is a lengthy process that they have to go through before they even set foot in our office.”

And he said “it may be inappropriate” to use certain hashtags or terminology, “even if it does ‘speak’ to the patients. Professionally, plastic surgeons should maintain a higher standard and maintain that even with their social media.”

Marci Bowers, MD, a gynecologic surgeon who performs gender-affirming procedures, and who is transgender herself, agreed.

“Some of the posts out there seem sensational, distasteful, and risk compromising patient confidentiality,” Dr. Bowers said in an interview.

“Much of this seemed to cross the line of good taste and appropriateness,” added Dr. Bowers, who is the incoming president of the World Professional Association for Transgender Health (WPATH). “Creating an idealized video without addressing risk is inappropriate and misleading,” she stressed.

“These surgeons would perhaps better serve their clients by focusing on and improving their clinical care,” she added.  

Dr. Bowers said that although WPATH has not addressed social media use in the past, its ethics committee will be taking on the topic this year.

Social media posts about gender-affirming procedures “don’t usually talk about the barriers, they don’t talk about bad outcomes, they tend to just focus on success stories,” said Gwendolyn P. Quinn, MD, a bioethicist, and Livia S. Wan, MD, professor of obstetrics and gynecology at the NYU Grossman School of Medicine.

But she also sees some positives. The posts can help normalize gender-affirming surgery, and post-procedure photos might “help people realize that they can’t just have everything exactly the way they want it to be,” said Dr. Quinn.
 

Does social media influence or educate?

Studies have documented the power of social media to influence desire and decisionmaking, especially when it comes to cosmetic surgery.

“The use of social media creates a vague area between patient confidentiality and entertainment,” writes Nisha Gupta and colleagues of the UCLA David Geffen School of Medicine in a review published in the Aesthetic Surgery Journal.

While social media use is on the rise by plastic surgeons and has the potential to educate, it has also “compromised the integrity of the doctor-patient relationship,” they add.

Surgeons can use tools to place themselves higher in searches, and patients might assume that those who have hundreds of thousands of followers “are the most qualified or trusted, although this is not always the case,” they note.

Markus Rach, PhD, a researcher with the University of Applied Sciences and Arts Northwestern Switzerland, analyzed the impact of TikTok’s plastic surgery content on how adolescents perceived themselves and how it influenced their decision to have a procedure.

Most TikTok users are under age 24, and #plasticsurgery has a huge viewership with some 3.8 billion views at the time of publication, said Dr. Rach. He found that influencers tended to make adolescents feel bad and want surgery but that plastic surgeons had a moderating effect on both negative feelings and the intent to get surgery.

Dr. Bowers said that, despite her concerns, she does not “believe social media influences like TikTok and Facebook create artificial demand.”

However, Dr. Mangubat said social media can make plastic surgery seem enticing. “It can happen, and it does happen,” he said, but he added that’s true for any cosmetic procedure, not just gender-affirming surgery.

The pitfall with social media is that “patients are being sold a vision of themselves that may or may not be possible,” he observed.

Dr. Quinn worries less about people being talked into a procedure and more about those who don’t want surgery.

“There are people who identify as transgender but do not feel the need to change any parts of their body,” she said. “And that should be okay.”
 

Concerns about minors

New guidance from WPATH, their Standards of Care (SOC) 8 – the first update in 10 years – are due to be published this month. As reported by this news organization, and as stated in the draft of the SOC 8 published for comment in December 2021, the organization has recommended lowering the age for “top” surgery from 18 to 15 years.

Dr. Clayton has concerns about young people with gender dysphoria, who she says are “often vulnerable youth, many of whom have comorbid psychiatric and neurodevelopmental disorders.”

“This may contribute to a greater vulnerability of this population to undue influence,” added Dr. Clayton.

Sean Devitt, MD, and Jeffrey M. Kenkel, MD, of the University of Texas Southwestern Medical Center, Dallas, expressed concern that social media posts by plastic surgeons could be especially dangerous for young people.

“Given that the prefrontal cortex, which is largely responsible for impulse control, is not fully developed until the age of 25, is it ethical to allow younger patients to make life-lasting decisions under the guise of education?” they ask in a commentary on the review by Ms. Gupta and colleagues about plastic surgeons’ use of social media. The review did not focus on gender-affirmation procedures.

Many surgeons – but not all – steer clear of genital (“bottom”) surgeries in minors. However, bilateral mastectomies are being performed in those as young as age 13 based on surgeons’ risk-benefit calculus for the patient.

A study, published in May in the Annals of Plastic Surgery, showed there was a 13-fold increase in the number of bilateral mastectomies performed on under-18s between January 2013 and the end of July 2020. Of the 209 minors (age 12-17) who had the surgery, two (0.95%) expressed regret by the time of follow-up, at 3 and 7 years post-operatively, but neither had reversal surgery.

A small 2018 study, published in JAMA Pediatrics, among trans males who had top surgery found high rates of satisfaction, though one of the 68 patients reported experiencing regret “sometimes.” The mean age of patients in the surgical group was 19 years and the youngest patient was 14.

“Most of us who practice heavily in this field will make exceptions, not for genital surgery but typically for top surgery,” said Dr. Gallagher, who added that she operates on one minor [under 18] a month, while doing some 400-500 gender-affirmative surgeries a year. For some patients, “doing nothing isn’t necessarily a no-harm option,” said Dr. Gallagher.

“Arbitrarily picking the age of 18 and sentencing that patient to another year of dysphoria” might not be the best risk-benefit calculus, she said.  

Dr. Mangubat agrees, especially if, for example, a trans man develops double D breasts by age 14. “You’ve sentenced them to 4 years of misery” before they can get insurance coverage, he said. His youngest top surgery patient was age 15. He said the person’s family, mental health professional, and primary care physician were all in favor of the procedure.

Dr. Mangubat also noted that some insurers, such as Kaiser Permanente, now cover bilateral mastectomy starting at age 16.

Dr. Quinn, the bioethicist, said not every minor or young adult is equipped to make the best long-term decisions.

She works with younger patients who have cancer, for example, and said her suggestions that they consider fertility preservation are often met with protestations “that they will never have children.”

The same issue arises with transgender patients. They may not want to think about having children or issues such as breast feeding while in their teens or early 20s. “But you know from your experience that they may feel differently in 10 years, but they’re just not in the mind frame to think about it,” said Dr. Quinn.

Some young people may accurately never want children, said Dr. Quinn, “but there is a lack of maturity shown when a person just shuts down a conversation and won’t even listen to infertility threats and potential preservation options.”  
 

Concerns about regret?

Dr. Gallagher said she follows the WPATH standards, which require mental health evaluations, and as a result, “the risk of regret is incredibly low.”

However, one of Dr. Gallagher’s patients who detransitioned, Grace, who goes by @HormoneHangover on social media, said she has taken umbrage at some of the Miami surgeon’s TikToks, including one, “Why might some patients feel sad after surgery ... despite wanting it for so long??”

“This is actually not uncommon with ANY kind of surgery, but it’s temporary!” said the TikTok text. Dr. Gallagher is wearing a red dress and heels and flips her hair while the text scrolls above her.

But to Grace, the TikTok “really bothered me, because sometimes there is regret, and I think that sort of advertising paints a falsely rosy picture,” she said in an interview.

And it is emblematic of what she feels was Dr. Gallagher’s “breezy” approach to explaining the procedure to her. “The surgery itself was a shocking experience for me,” she said. “The physical experience was very jarring. It was very disturbing in a way I hadn’t anticipated or understood in advance,” said Grace.

Dr. Mangubat, who does 100 bilateral mastectomies in trans patients a year, said he goes to great lengths to ensure his patients are good candidates. Everyone – even those who self-pay – must have counseling, and if the individual seems to be considering the surgery because it’s “trendy,” he steers clear.

“If they’re not serious about it, I don’t want to operate on them,” said Dr. Mangubat. “There have been maybe two patients who have come back” to detransition, he said. 

Dr. Hadeed also said he has not seen regret. He attributes this to his vetting process, which includes investigating the background of the mental health professionals who write support letters.

“We’ve turned away a lot of patients from our office either because of inadequate letters or because the person writing the letter just doesn’t really have any proper credentials,” he said.
 

Is social media use by plastic surgeons the new normal?

With so many plastic surgeons – including those who perform transgender procedures – using social media, it may increasingly be just part of doing business.

“Undoubtedly gender surgery teams will have a greater presence on social media in the future,” write Alireza Hamidian Jahromi, MD, and a colleague of the plastic surgery department at Rush University Medical Center, Chicago, in a letter published in Plastic and Reconstructive Surgery.  

Kyle R. Latack, MD, and colleagues at the University of Southern California and the University of Michigan, have studied the use of social media by the transgender community and write that they believe “there should be an increased effort to develop high-quality and unbiased resources for patient education that can be made [available] on social media.”

Dr. Gallagher said TikTok helped her erase fear. “A bilateral mastectomy is a scary surgery for an 18-year-old or a 20-year-old,” she said, “but they have to do it for their well-being.”

“That is a criticism I’ve heard – that I seek to minimize it or that I’m flippant about it,” said Dr. Gallagher.

For “top surgery the risk profile is pretty low,” she said, “so what I try to do is educate people that it’s maybe not as scary a procedure as they think.”

Dr. Mangubat, however, is concerned about some of what he sees, especially the explosion of surgeons offering gender-affirming procedures. “Now everybody wants a piece of it,” he said.

“Let’s face it, it’s money now. You get paid for doing this surgery. Hospitals get paid a lot of money for their operating rooms for doing the surgery,” said Dr. Mangubat. “There are some surgeons who believe the transgender community is just another market.”

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

A woman wearing purple surgical scrubs stares into a camera, looking frustrated, but doesn’t speak. Superimposed over her head is the text “just realized I only get to Yeet 4 Teets next week,” and a crying emoji. Rain appears to drip down over her while “Stan” by Eminem plays in the background.

That October 2020 TikTok by Sidhbh Gallagher, MD, a Miami-based plastic surgeon known as @gendersurgeon, had almost 10,000 likes and was tagged #topsurgery, #masculoplasty, #ftm, and #transman, among other hashtags.

“What health check do I have to get in preparation for teetus deletus?” is the question in another Dr. Gallagher TikTok. Dr. Gallagher is a prolific user of social media with over 268K TikTok followers and over 44K Instagram followers. Another Dr. Gallagher TikTok account, @thevagicianmd, has some 7K followers.

Another cosmetic surgeon, Tony Mangubat, MD, known as @Tikdoctony to his more than 200K followers, uses similar hashtags – like #teetusdeleetus – in his TikToks.

Clearly not medical terms, hashtags like #yeettheteet and #teetusdeletus are often used by the transgender community. The posts by Dr. Gallagher and Dr. Mangubat are part of an ever-growing wave of social media activity by medical professionals.  

Plastic surgeons have never been shy about advertising their work – and many have taken to social media to do so, including showing before and after photos. A 2020 study published in Plastic and Reconstructive Surgery found that the majority of such surgeons, especially those in private practice, use social media.

But the use of TikTok, Instagram, and other social media platforms by surgeons who specialize in gender reassignment raises questions about the appropriateness of promoting such procedures, especially to a younger-skewing audience.

Because of the limits on pornography and nudity of social media platforms, most social media posts by gender surgeons are about female-to-male (FTM) mastectomies, the fastest-growing transgender procedure.

The American Society of Plastic Surgeons (ASPS) started separately tracking gender-affirmation procedures in 2015. That year, members reported doing 1,360 FTM procedures.

In 2020, the ASPS further separated procedures into additional categories. That year – when many surgeries were postponed because of the COVID-19 pandemic – FTM mastectomies grew by 15%, with 8,548 procedures performed, a far greater number than for any other transgender surgery, and a sixfold increase in the number of procedures done in 2015.
 

‘Gimmicky,’ but building community

Surgeons interviewed for this article said they use social media primarily to connect with patients and to educate in a light-hearted way.

While Dr. Gallagher acknowledges that using #teetusdeletus is “kind of gimmicky,” she said she doesn’t view it as unprofessional because she is “using the words of the community I serve.” Many of her patients have seen a medical professional “who just didn’t understand what it is to have gender dysphoria, didn’t understand what it is to be trans, so going from that experience to somebody who uses the same language as the community uses can be quite a comfortable experience,” she said in an interview.

Dr. Mangubat, a Seattle-area plastic surgeon who has been doing mastectomies for trans male patients since 1988, said he tailors his TikToks to that group. He likes TikTok – which he started using in early 2021 – because it has rules against bullying, swearing, and pornography, he told this news organization.

“It’s really not ... advertising ... it’s a community-building platform,” said Dr. Mangubat. “If you build community, people will trust you, and if you provide good accurate information, then people will be safer,” he said. 

But, “I’m not telling them to come to me,” he stressed.

He always appears in scrubs and doesn’t do music, doesn’t dance, and doesn’t post before and after photos, but he still gets thousands – or sometimes hundreds of thousands – of likes.

His mission, he said, is to answer the community’s questions. “We’re reaching patients that have had their top surgery, that are going to have their top surgery, that are looking for how to get top surgery, that are just starting on testosterone, that haven’t started on testosterone – it’s the whole spectrum of patients,” said Dr. Mangubat.
 

Risks downplayed?

Other surgeons have expressed concern about ethical boundaries and the tendency of social media posts to downplay risks of what are life-changing procedures.

A 2020 study of YouTube videos on top surgery, for instance, concluded that “there were no unbiased videos by board-certified plastic surgeons explaining the risks, benefits, treatment options, and alternatives to surgery.”

Alison Clayton, MBBS, an Australian psychiatrist, said that social media posts can create false expectations because they emphasize style over substance, omit risks, and can create an unwarranted sense of trust in the doctor that can spill over into the physician-patient relationship.

Dr. Clayton also believes that “the gender-affirming surgical procedures being offered to these youth have a scant empirical evidence base for benefits to psychological health and well-being.”

It is known that a number of those who transition, using either opposite sex hormones and/or surgical procedures, later have regret and “detransition,” but statistics are lacking. It is also a controversial area, with many detransitioners saying they didn’t get appropriate care and weren’t properly assessed before being given hormones or heading to surgery.

Most of the gender surgeons interviewed for this article said they see almost “zero” regret if proper mental health evaluations are performed before surgery, and they added, the procedures can relieve dysphoria.

Nevertheless, posts should not be “all fun and games,” said Josef Hadeed, MD, chair of the ASPS Patient Safety Committee and Public Education Committee and a member of its Social Media Subcommittee.

“When someone makes a decision to undergo a surgical procedure, they should be very aware there are some risks and potentially serious risks involved,” he told this news organization.

The ASPS “wants members to use social media in a judicious manner” in a way that educates the public and encourages patients to learn about a procedure and to consult with board-certified plastic surgeons, said Dr. Hadeed.

The Beverly Hills, Calif.–based surgeon does gender-affirmation procedures himself and uses Instagram, on which he has 53.4K followers, to educate patients and highlight his work using before and after photos.

“I like to think I do it in a very tasteful way,” Dr. Hadeed said. “It’s not in a way that’s sort of suggestive to patients, including minors, that this is something they need to get done, because if they are thinking about getting it done there is a lengthy process that they have to go through before they even set foot in our office.”

And he said “it may be inappropriate” to use certain hashtags or terminology, “even if it does ‘speak’ to the patients. Professionally, plastic surgeons should maintain a higher standard and maintain that even with their social media.”

Marci Bowers, MD, a gynecologic surgeon who performs gender-affirming procedures, and who is transgender herself, agreed.

“Some of the posts out there seem sensational, distasteful, and risk compromising patient confidentiality,” Dr. Bowers said in an interview.

“Much of this seemed to cross the line of good taste and appropriateness,” added Dr. Bowers, who is the incoming president of the World Professional Association for Transgender Health (WPATH). “Creating an idealized video without addressing risk is inappropriate and misleading,” she stressed.

“These surgeons would perhaps better serve their clients by focusing on and improving their clinical care,” she added.  

Dr. Bowers said that although WPATH has not addressed social media use in the past, its ethics committee will be taking on the topic this year.

Social media posts about gender-affirming procedures “don’t usually talk about the barriers, they don’t talk about bad outcomes, they tend to just focus on success stories,” said Gwendolyn P. Quinn, MD, a bioethicist, and Livia S. Wan, MD, professor of obstetrics and gynecology at the NYU Grossman School of Medicine.

But she also sees some positives. The posts can help normalize gender-affirming surgery, and post-procedure photos might “help people realize that they can’t just have everything exactly the way they want it to be,” said Dr. Quinn.
 

Does social media influence or educate?

Studies have documented the power of social media to influence desire and decisionmaking, especially when it comes to cosmetic surgery.

“The use of social media creates a vague area between patient confidentiality and entertainment,” writes Nisha Gupta and colleagues of the UCLA David Geffen School of Medicine in a review published in the Aesthetic Surgery Journal.

While social media use is on the rise by plastic surgeons and has the potential to educate, it has also “compromised the integrity of the doctor-patient relationship,” they add.

Surgeons can use tools to place themselves higher in searches, and patients might assume that those who have hundreds of thousands of followers “are the most qualified or trusted, although this is not always the case,” they note.

Markus Rach, PhD, a researcher with the University of Applied Sciences and Arts Northwestern Switzerland, analyzed the impact of TikTok’s plastic surgery content on how adolescents perceived themselves and how it influenced their decision to have a procedure.

Most TikTok users are under age 24, and #plasticsurgery has a huge viewership with some 3.8 billion views at the time of publication, said Dr. Rach. He found that influencers tended to make adolescents feel bad and want surgery but that plastic surgeons had a moderating effect on both negative feelings and the intent to get surgery.

Dr. Bowers said that, despite her concerns, she does not “believe social media influences like TikTok and Facebook create artificial demand.”

However, Dr. Mangubat said social media can make plastic surgery seem enticing. “It can happen, and it does happen,” he said, but he added that’s true for any cosmetic procedure, not just gender-affirming surgery.

The pitfall with social media is that “patients are being sold a vision of themselves that may or may not be possible,” he observed.

Dr. Quinn worries less about people being talked into a procedure and more about those who don’t want surgery.

“There are people who identify as transgender but do not feel the need to change any parts of their body,” she said. “And that should be okay.”
 

Concerns about minors

New guidance from WPATH, their Standards of Care (SOC) 8 – the first update in 10 years – are due to be published this month. As reported by this news organization, and as stated in the draft of the SOC 8 published for comment in December 2021, the organization has recommended lowering the age for “top” surgery from 18 to 15 years.

Dr. Clayton has concerns about young people with gender dysphoria, who she says are “often vulnerable youth, many of whom have comorbid psychiatric and neurodevelopmental disorders.”

“This may contribute to a greater vulnerability of this population to undue influence,” added Dr. Clayton.

Sean Devitt, MD, and Jeffrey M. Kenkel, MD, of the University of Texas Southwestern Medical Center, Dallas, expressed concern that social media posts by plastic surgeons could be especially dangerous for young people.

“Given that the prefrontal cortex, which is largely responsible for impulse control, is not fully developed until the age of 25, is it ethical to allow younger patients to make life-lasting decisions under the guise of education?” they ask in a commentary on the review by Ms. Gupta and colleagues about plastic surgeons’ use of social media. The review did not focus on gender-affirmation procedures.

Many surgeons – but not all – steer clear of genital (“bottom”) surgeries in minors. However, bilateral mastectomies are being performed in those as young as age 13 based on surgeons’ risk-benefit calculus for the patient.

A study, published in May in the Annals of Plastic Surgery, showed there was a 13-fold increase in the number of bilateral mastectomies performed on under-18s between January 2013 and the end of July 2020. Of the 209 minors (age 12-17) who had the surgery, two (0.95%) expressed regret by the time of follow-up, at 3 and 7 years post-operatively, but neither had reversal surgery.

A small 2018 study, published in JAMA Pediatrics, among trans males who had top surgery found high rates of satisfaction, though one of the 68 patients reported experiencing regret “sometimes.” The mean age of patients in the surgical group was 19 years and the youngest patient was 14.

“Most of us who practice heavily in this field will make exceptions, not for genital surgery but typically for top surgery,” said Dr. Gallagher, who added that she operates on one minor [under 18] a month, while doing some 400-500 gender-affirmative surgeries a year. For some patients, “doing nothing isn’t necessarily a no-harm option,” said Dr. Gallagher.

“Arbitrarily picking the age of 18 and sentencing that patient to another year of dysphoria” might not be the best risk-benefit calculus, she said.  

Dr. Mangubat agrees, especially if, for example, a trans man develops double D breasts by age 14. “You’ve sentenced them to 4 years of misery” before they can get insurance coverage, he said. His youngest top surgery patient was age 15. He said the person’s family, mental health professional, and primary care physician were all in favor of the procedure.

Dr. Mangubat also noted that some insurers, such as Kaiser Permanente, now cover bilateral mastectomy starting at age 16.

Dr. Quinn, the bioethicist, said not every minor or young adult is equipped to make the best long-term decisions.

She works with younger patients who have cancer, for example, and said her suggestions that they consider fertility preservation are often met with protestations “that they will never have children.”

The same issue arises with transgender patients. They may not want to think about having children or issues such as breast feeding while in their teens or early 20s. “But you know from your experience that they may feel differently in 10 years, but they’re just not in the mind frame to think about it,” said Dr. Quinn.

Some young people may accurately never want children, said Dr. Quinn, “but there is a lack of maturity shown when a person just shuts down a conversation and won’t even listen to infertility threats and potential preservation options.”  
 

Concerns about regret?

Dr. Gallagher said she follows the WPATH standards, which require mental health evaluations, and as a result, “the risk of regret is incredibly low.”

However, one of Dr. Gallagher’s patients who detransitioned, Grace, who goes by @HormoneHangover on social media, said she has taken umbrage at some of the Miami surgeon’s TikToks, including one, “Why might some patients feel sad after surgery ... despite wanting it for so long??”

“This is actually not uncommon with ANY kind of surgery, but it’s temporary!” said the TikTok text. Dr. Gallagher is wearing a red dress and heels and flips her hair while the text scrolls above her.

But to Grace, the TikTok “really bothered me, because sometimes there is regret, and I think that sort of advertising paints a falsely rosy picture,” she said in an interview.

And it is emblematic of what she feels was Dr. Gallagher’s “breezy” approach to explaining the procedure to her. “The surgery itself was a shocking experience for me,” she said. “The physical experience was very jarring. It was very disturbing in a way I hadn’t anticipated or understood in advance,” said Grace.

Dr. Mangubat, who does 100 bilateral mastectomies in trans patients a year, said he goes to great lengths to ensure his patients are good candidates. Everyone – even those who self-pay – must have counseling, and if the individual seems to be considering the surgery because it’s “trendy,” he steers clear.

“If they’re not serious about it, I don’t want to operate on them,” said Dr. Mangubat. “There have been maybe two patients who have come back” to detransition, he said. 

Dr. Hadeed also said he has not seen regret. He attributes this to his vetting process, which includes investigating the background of the mental health professionals who write support letters.

“We’ve turned away a lot of patients from our office either because of inadequate letters or because the person writing the letter just doesn’t really have any proper credentials,” he said.
 

Is social media use by plastic surgeons the new normal?

With so many plastic surgeons – including those who perform transgender procedures – using social media, it may increasingly be just part of doing business.

“Undoubtedly gender surgery teams will have a greater presence on social media in the future,” write Alireza Hamidian Jahromi, MD, and a colleague of the plastic surgery department at Rush University Medical Center, Chicago, in a letter published in Plastic and Reconstructive Surgery.  

Kyle R. Latack, MD, and colleagues at the University of Southern California and the University of Michigan, have studied the use of social media by the transgender community and write that they believe “there should be an increased effort to develop high-quality and unbiased resources for patient education that can be made [available] on social media.”

Dr. Gallagher said TikTok helped her erase fear. “A bilateral mastectomy is a scary surgery for an 18-year-old or a 20-year-old,” she said, “but they have to do it for their well-being.”

“That is a criticism I’ve heard – that I seek to minimize it or that I’m flippant about it,” said Dr. Gallagher.

For “top surgery the risk profile is pretty low,” she said, “so what I try to do is educate people that it’s maybe not as scary a procedure as they think.”

Dr. Mangubat, however, is concerned about some of what he sees, especially the explosion of surgeons offering gender-affirming procedures. “Now everybody wants a piece of it,” he said.

“Let’s face it, it’s money now. You get paid for doing this surgery. Hospitals get paid a lot of money for their operating rooms for doing the surgery,” said Dr. Mangubat. “There are some surgeons who believe the transgender community is just another market.”

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

Pregnant women with polycystic ovary syndrome (PCOS) appear to be at significantly increased risk of experiencing cardiac complications while hospitalized during and after delivery.

An estimated 5 million women of childbearing age in the United States have PCOS, a hormone disorder linked to infertility. PCOS is also known to contribute to the development of cardiometabolic abnormalities like high cholesterol and high blood pressure, which are associated with acute cardiovascular complications during delivery.

But a study, published online  in the Journal of the American Heart Association, found that even after accounting for pre-eclampsia, age, comorbidities, and race, PCOS was linked to a 76% increased risk for heart failure, a 79% higher risk of a weakened heart, and an 82% increased risk of having blood clots in the hours and days around giving birth in hospital settings, compared with women without PCOS.

“Perhaps women need a closer follow-up during their pregnancy,” said Erin Michos, MD, MHS, associate director of preventive cardiology at Johns Hopkins Medicine, Baltimore, and a co-author of the study. “They’re counseled about the difficulties of getting pregnant, but what about when they get pregnant?”

Hospitalizations of women with PCOS were also associated with longer stays (3 vs. 2 days) and higher costs ($4,901 vs. $3616; P < .01), compared with women without PCOS.

Over the 17-year analysis period, the number of women with PCOS rose from 569 per 100,000 deliveries to 15,349 per 100,000 deliveries. The researchers attributed the increase in part to greater awareness and diagnosis of the disorder. Dr. Michos and her colleagues used the National Inpatient Sample, managed by the Agency for Healthcare Research and Quality, to pull claims data for women who gave birth in hospitals between 2002 and 2019.
 

Solutions?

Dr. Michos said there may be more prevention work from og.gyns. to both educate patients about their heart risks during the delivery process and also to refer them to relevant cardiac specialists.

“These women may seek out a gynecologist because of the symptoms, perhaps irregular menses, but along with that should come counseling of the long-term cardiovascular complication,” Dr. Michos said. “And after a pregnancy there should be a good handoff to a primary care provider, so they get a cardiovascular assessment.”

Lifestyle management before, during, and after pregnancy can help prevent the onset of the long-term consequences of cardiac complications during delivery, according to Valerie Baker, MD, director of the division of reproductive endocrinology and infertility at Hopkins Medicine, and her colleagues in a viewpoint published in the journal Fertility and Sterility.

“Once women with PCOS are identified by screening to be at higher risk for [cardiovascular disease], the foundational approach should be lifestyle management followed by statin therapy,” Dr. Baker’s group wrote. “These interventions should include dietary management and physical activity, especially for those who are prediabetic.”

The current study came on the heels of a June 14 meta-analysis by Dr. Michos’ group that found that women with PCOS may be twice as likely as those without PCOS to have coronary artery calcification, a precursor to atherosclerosis and a sign of the early onset of cardiovascular disease.

“We shouldn’t assume that all women of reproductive age are low risk,” Dr. Michos said. “This is the window of time that we can reshape the trajectory early in life.”

The study was supported by the Amato Fund for Women’s Cardiovascular Health research at Johns Hopkins University and through grant support from the American Heart Association (940166). Dr. Michos reported advisory board participation for AstraZeneca, Amarin, Novartis, Novo Nordisk, Bayer, Boehringer Ingelheim, Esperion, and Pfizer. Study coauthor Michael Honigberg, MD, reported consulting fees from CRISPR Therapeutics, unrelated to the present work. The remaining authors have disclosed no relevant financial relationships.

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

Pregnant women with polycystic ovary syndrome (PCOS) appear to be at significantly increased risk of experiencing cardiac complications while hospitalized during and after delivery.

An estimated 5 million women of childbearing age in the United States have PCOS, a hormone disorder linked to infertility. PCOS is also known to contribute to the development of cardiometabolic abnormalities like high cholesterol and high blood pressure, which are associated with acute cardiovascular complications during delivery.

But a study, published online  in the Journal of the American Heart Association, found that even after accounting for pre-eclampsia, age, comorbidities, and race, PCOS was linked to a 76% increased risk for heart failure, a 79% higher risk of a weakened heart, and an 82% increased risk of having blood clots in the hours and days around giving birth in hospital settings, compared with women without PCOS.

“Perhaps women need a closer follow-up during their pregnancy,” said Erin Michos, MD, MHS, associate director of preventive cardiology at Johns Hopkins Medicine, Baltimore, and a co-author of the study. “They’re counseled about the difficulties of getting pregnant, but what about when they get pregnant?”

Hospitalizations of women with PCOS were also associated with longer stays (3 vs. 2 days) and higher costs ($4,901 vs. $3616; P < .01), compared with women without PCOS.

Over the 17-year analysis period, the number of women with PCOS rose from 569 per 100,000 deliveries to 15,349 per 100,000 deliveries. The researchers attributed the increase in part to greater awareness and diagnosis of the disorder. Dr. Michos and her colleagues used the National Inpatient Sample, managed by the Agency for Healthcare Research and Quality, to pull claims data for women who gave birth in hospitals between 2002 and 2019.
 

Solutions?

Dr. Michos said there may be more prevention work from og.gyns. to both educate patients about their heart risks during the delivery process and also to refer them to relevant cardiac specialists.

“These women may seek out a gynecologist because of the symptoms, perhaps irregular menses, but along with that should come counseling of the long-term cardiovascular complication,” Dr. Michos said. “And after a pregnancy there should be a good handoff to a primary care provider, so they get a cardiovascular assessment.”

Lifestyle management before, during, and after pregnancy can help prevent the onset of the long-term consequences of cardiac complications during delivery, according to Valerie Baker, MD, director of the division of reproductive endocrinology and infertility at Hopkins Medicine, and her colleagues in a viewpoint published in the journal Fertility and Sterility.

“Once women with PCOS are identified by screening to be at higher risk for [cardiovascular disease], the foundational approach should be lifestyle management followed by statin therapy,” Dr. Baker’s group wrote. “These interventions should include dietary management and physical activity, especially for those who are prediabetic.”

The current study came on the heels of a June 14 meta-analysis by Dr. Michos’ group that found that women with PCOS may be twice as likely as those without PCOS to have coronary artery calcification, a precursor to atherosclerosis and a sign of the early onset of cardiovascular disease.

“We shouldn’t assume that all women of reproductive age are low risk,” Dr. Michos said. “This is the window of time that we can reshape the trajectory early in life.”

The study was supported by the Amato Fund for Women’s Cardiovascular Health research at Johns Hopkins University and through grant support from the American Heart Association (940166). Dr. Michos reported advisory board participation for AstraZeneca, Amarin, Novartis, Novo Nordisk, Bayer, Boehringer Ingelheim, Esperion, and Pfizer. Study coauthor Michael Honigberg, MD, reported consulting fees from CRISPR Therapeutics, unrelated to the present work. The remaining authors have disclosed no relevant financial relationships.

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

Pregnant women with polycystic ovary syndrome (PCOS) appear to be at significantly increased risk of experiencing cardiac complications while hospitalized during and after delivery.

An estimated 5 million women of childbearing age in the United States have PCOS, a hormone disorder linked to infertility. PCOS is also known to contribute to the development of cardiometabolic abnormalities like high cholesterol and high blood pressure, which are associated with acute cardiovascular complications during delivery.

But a study, published online  in the Journal of the American Heart Association, found that even after accounting for pre-eclampsia, age, comorbidities, and race, PCOS was linked to a 76% increased risk for heart failure, a 79% higher risk of a weakened heart, and an 82% increased risk of having blood clots in the hours and days around giving birth in hospital settings, compared with women without PCOS.

“Perhaps women need a closer follow-up during their pregnancy,” said Erin Michos, MD, MHS, associate director of preventive cardiology at Johns Hopkins Medicine, Baltimore, and a co-author of the study. “They’re counseled about the difficulties of getting pregnant, but what about when they get pregnant?”

Hospitalizations of women with PCOS were also associated with longer stays (3 vs. 2 days) and higher costs ($4,901 vs. $3616; P < .01), compared with women without PCOS.

Over the 17-year analysis period, the number of women with PCOS rose from 569 per 100,000 deliveries to 15,349 per 100,000 deliveries. The researchers attributed the increase in part to greater awareness and diagnosis of the disorder. Dr. Michos and her colleagues used the National Inpatient Sample, managed by the Agency for Healthcare Research and Quality, to pull claims data for women who gave birth in hospitals between 2002 and 2019.
 

Solutions?

Dr. Michos said there may be more prevention work from og.gyns. to both educate patients about their heart risks during the delivery process and also to refer them to relevant cardiac specialists.

“These women may seek out a gynecologist because of the symptoms, perhaps irregular menses, but along with that should come counseling of the long-term cardiovascular complication,” Dr. Michos said. “And after a pregnancy there should be a good handoff to a primary care provider, so they get a cardiovascular assessment.”

Lifestyle management before, during, and after pregnancy can help prevent the onset of the long-term consequences of cardiac complications during delivery, according to Valerie Baker, MD, director of the division of reproductive endocrinology and infertility at Hopkins Medicine, and her colleagues in a viewpoint published in the journal Fertility and Sterility.

“Once women with PCOS are identified by screening to be at higher risk for [cardiovascular disease], the foundational approach should be lifestyle management followed by statin therapy,” Dr. Baker’s group wrote. “These interventions should include dietary management and physical activity, especially for those who are prediabetic.”

The current study came on the heels of a June 14 meta-analysis by Dr. Michos’ group that found that women with PCOS may be twice as likely as those without PCOS to have coronary artery calcification, a precursor to atherosclerosis and a sign of the early onset of cardiovascular disease.

“We shouldn’t assume that all women of reproductive age are low risk,” Dr. Michos said. “This is the window of time that we can reshape the trajectory early in life.”

The study was supported by the Amato Fund for Women’s Cardiovascular Health research at Johns Hopkins University and through grant support from the American Heart Association (940166). Dr. Michos reported advisory board participation for AstraZeneca, Amarin, Novartis, Novo Nordisk, Bayer, Boehringer Ingelheim, Esperion, and Pfizer. Study coauthor Michael Honigberg, MD, reported consulting fees from CRISPR Therapeutics, unrelated to the present work. The remaining authors have disclosed no relevant financial relationships.

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

New risk thresholds used to guide statin therapy for primary prevention of atherosclerotic cardiovascular disease in the latest European guidelines dramatically reduce eligibility for statin use in low-risk countries, a new study has found.

The authors reported that new risk thresholds that were chosen for statin treatment in the 2021 European Society of Cardiology guidelines reduce statin eligibility to only 4% of the target population and essentially eliminate a statin indication in women.

“We have guidelines in place to try to prevent cardiovascular disease but the risk threshold in this new guideline means that almost nobody qualifies for treatment in many countries, which will lead to almost no prevention of future cardiovascular disease in those countries,” lead author Martin Bødtker Mortensen, MD, PhD, Aarhus (Denmark) University Hospital, commented in an interview.

“We argue that the risk thresholds need to be lowered to get the statin eligibility in European countries to be in line with thresholds in the U.K. and U.S., which are based on randomized, controlled trials,” he added.

The study was published online in JAMA Cardiology.

An accompanying editorial describes the results of the study as “alarming,” and, if confirmed, said the guidelines should be revisited to “prevent a step backwards in the use of statins in primary prevention.”

For the study, Dr. Mortensen and colleagues set out to compare the clinical performance of the new European prevention guidelines with American College of Cardiology/American Heart Association, United Kingdom–National Institute for Health and Care Excellence, and the 2019 European guidelines in a contemporary European cohort of 66,909 apparently healthy individuals from the Copenhagen General Population Study.

During the 9-year follow-up, a range of 2,962-4,277 nonfatal and fatal cardiovascular events was observed, as defined by the models in the various guidelines.

Results showed that although the new 2021 European guidelines introduced a new and improved risk model, known as SCORE2, the updated age-specific recommendations dramatically reduced eligibility for a class I recommendation for statin therapy to only 4% of individuals, aged 40-69 years, and less than 1% of women.

This is in sharp contrast to the previous 2019 European guidelines as well as current UK-NICE and US-ACC/AHA guidelines that provide class I/strong recommendations to 20%, 26%, and 34% of individuals, respectively, with better clinical performance in both men and women, the authors report.

The researchers also reported other analyses in which the sensitivity of the new European guidelines was improved considerably by lowering the treatment thresholds.

Dr. Mortensen explained to this news organization that the original SCORE risk model used in ESC guidelines was problematic as it only predicts the 10-year risk of fatal atherosclerotic cardiovascular events, whereas those from the United States and United Kingdom used both fatal and nonfatal cardiovascular events.

“Now the ESC has updated its model and the new model is much better in that it predicts both fatal and nonfatal events, and the predicted risk correlates well with the actual risk. So that’s a big step forward. However, the new thresholds for statin treatment are far too high for low-risk European countries because very few individuals will now qualify for statin therapy,” he said.

“The problem is that, if we use these guidelines, the vast majority of those individuals who will develop cardiovascular disease within 10 years will not be assigned statin therapy that can reduce this risk. There will be lots of individuals who are at high risk of cardiovascular disease, but these guidelines will not identify them as needing to take a statin,” Dr. Mortensen commented.

“If we use the U.K. or U.S. guidelines, far more people in these low-risk European countries would be eligible for statin therapy and we would prevent far more events than if we use the new ESC guidelines,” he added.

Dr. Mortensen explained that the problem arises from having four different risk score models in Europe for areas at different risk, but they all use the same risk thresholds for statin treatment.

“In general, Eastern European countries have higher risk than Western European countries, so these guidelines may work quite well in Eastern European countries but in low-risk Western European countries, where the low-risk score model is used, very few people will qualify for statin therapy,” he said.

While Dr. Mortensen is not against the idea of different risk models in areas that have different risks, he says this needs to be accompanied by different risk thresholds in the different risk areas.

Asked whether there is an argument that most individuals in low-risk countries may not need to take a statin, Dr. Mortensen countered: “One of the reasons the risk is low in many of these European countries is the high use of preventative medication. So, if a threshold that is too high is used most people will not take a statin anymore and the risk in these countries will increase again.”

Authors of the accompanying editorial, Ann Marie Navar, MD, PhD, University of Texas Southwestern Medical Center, Dallas; Gregg C. Fonarow, MD, University of California, Los Angeles; and Michael J. Pencina, PhD, Duke University Medical Center, Durham, N.C., agreed with Dr. Mortensen that the problems appear to arise from use of a risk score that is highly influenced by regional cardiovascular burden.

They point out that under the current guidelines, a 55-year-old woman (smoker; systolic blood pressure, 130 mm Hg; non–HDL cholesterol, 4.0 mmol/L) would have a 10-year predicted risk of having a cardiovascular event of 5% in Denmark but a predicted risk of 18% in Romania.

“While there may be regional differences in environmental risk factors, location alone should not cause a fourfold difference in an individual’s predicted cardiovascular risk,” they wrote.

The editorialists also elaborated on Dr. Mortensen’s point that the new guideline creates a system that eventually becomes a victim of its own success.

“As countries are successful in implementing statin therapy to lower CVD, CVD rates drop, and progressively fewer individuals are then eligible for the very therapy that contributed to the decline in CVD in the first place,” they noted.

The editorialists called for the analysis to be replicated in other low-risk countries and extended to higher-risk regions, with a focus on potential overtreatment of men and older adults.

“If confirmed, the present findings should be a catalyst for the ESC to revisit or augment their current guidelines to prevent a step backward in the use of statins in primary prevention,” they concluded.

This news organization asked the ESC for a response to the findings, but did not comment by press time.

This work was supported by the Lundbeck Foundation, Herlev and Gentofte Hospital, Copenhagen University Hospital, the Copenhagen County Foundation, and Aarhus University, Denmark. Dr. Mortensen reported no disclosures.

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

New risk thresholds used to guide statin therapy for primary prevention of atherosclerotic cardiovascular disease in the latest European guidelines dramatically reduce eligibility for statin use in low-risk countries, a new study has found.

The authors reported that new risk thresholds that were chosen for statin treatment in the 2021 European Society of Cardiology guidelines reduce statin eligibility to only 4% of the target population and essentially eliminate a statin indication in women.

“We have guidelines in place to try to prevent cardiovascular disease but the risk threshold in this new guideline means that almost nobody qualifies for treatment in many countries, which will lead to almost no prevention of future cardiovascular disease in those countries,” lead author Martin Bødtker Mortensen, MD, PhD, Aarhus (Denmark) University Hospital, commented in an interview.

“We argue that the risk thresholds need to be lowered to get the statin eligibility in European countries to be in line with thresholds in the U.K. and U.S., which are based on randomized, controlled trials,” he added.

The study was published online in JAMA Cardiology.

An accompanying editorial describes the results of the study as “alarming,” and, if confirmed, said the guidelines should be revisited to “prevent a step backwards in the use of statins in primary prevention.”

For the study, Dr. Mortensen and colleagues set out to compare the clinical performance of the new European prevention guidelines with American College of Cardiology/American Heart Association, United Kingdom–National Institute for Health and Care Excellence, and the 2019 European guidelines in a contemporary European cohort of 66,909 apparently healthy individuals from the Copenhagen General Population Study.

During the 9-year follow-up, a range of 2,962-4,277 nonfatal and fatal cardiovascular events was observed, as defined by the models in the various guidelines.

Results showed that although the new 2021 European guidelines introduced a new and improved risk model, known as SCORE2, the updated age-specific recommendations dramatically reduced eligibility for a class I recommendation for statin therapy to only 4% of individuals, aged 40-69 years, and less than 1% of women.

This is in sharp contrast to the previous 2019 European guidelines as well as current UK-NICE and US-ACC/AHA guidelines that provide class I/strong recommendations to 20%, 26%, and 34% of individuals, respectively, with better clinical performance in both men and women, the authors report.

The researchers also reported other analyses in which the sensitivity of the new European guidelines was improved considerably by lowering the treatment thresholds.

Dr. Mortensen explained to this news organization that the original SCORE risk model used in ESC guidelines was problematic as it only predicts the 10-year risk of fatal atherosclerotic cardiovascular events, whereas those from the United States and United Kingdom used both fatal and nonfatal cardiovascular events.

“Now the ESC has updated its model and the new model is much better in that it predicts both fatal and nonfatal events, and the predicted risk correlates well with the actual risk. So that’s a big step forward. However, the new thresholds for statin treatment are far too high for low-risk European countries because very few individuals will now qualify for statin therapy,” he said.

“The problem is that, if we use these guidelines, the vast majority of those individuals who will develop cardiovascular disease within 10 years will not be assigned statin therapy that can reduce this risk. There will be lots of individuals who are at high risk of cardiovascular disease, but these guidelines will not identify them as needing to take a statin,” Dr. Mortensen commented.

“If we use the U.K. or U.S. guidelines, far more people in these low-risk European countries would be eligible for statin therapy and we would prevent far more events than if we use the new ESC guidelines,” he added.

Dr. Mortensen explained that the problem arises from having four different risk score models in Europe for areas at different risk, but they all use the same risk thresholds for statin treatment.

“In general, Eastern European countries have higher risk than Western European countries, so these guidelines may work quite well in Eastern European countries but in low-risk Western European countries, where the low-risk score model is used, very few people will qualify for statin therapy,” he said.

While Dr. Mortensen is not against the idea of different risk models in areas that have different risks, he says this needs to be accompanied by different risk thresholds in the different risk areas.

Asked whether there is an argument that most individuals in low-risk countries may not need to take a statin, Dr. Mortensen countered: “One of the reasons the risk is low in many of these European countries is the high use of preventative medication. So, if a threshold that is too high is used most people will not take a statin anymore and the risk in these countries will increase again.”

Authors of the accompanying editorial, Ann Marie Navar, MD, PhD, University of Texas Southwestern Medical Center, Dallas; Gregg C. Fonarow, MD, University of California, Los Angeles; and Michael J. Pencina, PhD, Duke University Medical Center, Durham, N.C., agreed with Dr. Mortensen that the problems appear to arise from use of a risk score that is highly influenced by regional cardiovascular burden.

They point out that under the current guidelines, a 55-year-old woman (smoker; systolic blood pressure, 130 mm Hg; non–HDL cholesterol, 4.0 mmol/L) would have a 10-year predicted risk of having a cardiovascular event of 5% in Denmark but a predicted risk of 18% in Romania.

“While there may be regional differences in environmental risk factors, location alone should not cause a fourfold difference in an individual’s predicted cardiovascular risk,” they wrote.

The editorialists also elaborated on Dr. Mortensen’s point that the new guideline creates a system that eventually becomes a victim of its own success.

“As countries are successful in implementing statin therapy to lower CVD, CVD rates drop, and progressively fewer individuals are then eligible for the very therapy that contributed to the decline in CVD in the first place,” they noted.

The editorialists called for the analysis to be replicated in other low-risk countries and extended to higher-risk regions, with a focus on potential overtreatment of men and older adults.

“If confirmed, the present findings should be a catalyst for the ESC to revisit or augment their current guidelines to prevent a step backward in the use of statins in primary prevention,” they concluded.

This news organization asked the ESC for a response to the findings, but did not comment by press time.

This work was supported by the Lundbeck Foundation, Herlev and Gentofte Hospital, Copenhagen University Hospital, the Copenhagen County Foundation, and Aarhus University, Denmark. Dr. Mortensen reported no disclosures.

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

New risk thresholds used to guide statin therapy for primary prevention of atherosclerotic cardiovascular disease in the latest European guidelines dramatically reduce eligibility for statin use in low-risk countries, a new study has found.

The authors reported that new risk thresholds that were chosen for statin treatment in the 2021 European Society of Cardiology guidelines reduce statin eligibility to only 4% of the target population and essentially eliminate a statin indication in women.

“We have guidelines in place to try to prevent cardiovascular disease but the risk threshold in this new guideline means that almost nobody qualifies for treatment in many countries, which will lead to almost no prevention of future cardiovascular disease in those countries,” lead author Martin Bødtker Mortensen, MD, PhD, Aarhus (Denmark) University Hospital, commented in an interview.

“We argue that the risk thresholds need to be lowered to get the statin eligibility in European countries to be in line with thresholds in the U.K. and U.S., which are based on randomized, controlled trials,” he added.

The study was published online in JAMA Cardiology.

An accompanying editorial describes the results of the study as “alarming,” and, if confirmed, said the guidelines should be revisited to “prevent a step backwards in the use of statins in primary prevention.”

For the study, Dr. Mortensen and colleagues set out to compare the clinical performance of the new European prevention guidelines with American College of Cardiology/American Heart Association, United Kingdom–National Institute for Health and Care Excellence, and the 2019 European guidelines in a contemporary European cohort of 66,909 apparently healthy individuals from the Copenhagen General Population Study.

During the 9-year follow-up, a range of 2,962-4,277 nonfatal and fatal cardiovascular events was observed, as defined by the models in the various guidelines.

Results showed that although the new 2021 European guidelines introduced a new and improved risk model, known as SCORE2, the updated age-specific recommendations dramatically reduced eligibility for a class I recommendation for statin therapy to only 4% of individuals, aged 40-69 years, and less than 1% of women.

This is in sharp contrast to the previous 2019 European guidelines as well as current UK-NICE and US-ACC/AHA guidelines that provide class I/strong recommendations to 20%, 26%, and 34% of individuals, respectively, with better clinical performance in both men and women, the authors report.

The researchers also reported other analyses in which the sensitivity of the new European guidelines was improved considerably by lowering the treatment thresholds.

Dr. Mortensen explained to this news organization that the original SCORE risk model used in ESC guidelines was problematic as it only predicts the 10-year risk of fatal atherosclerotic cardiovascular events, whereas those from the United States and United Kingdom used both fatal and nonfatal cardiovascular events.

“Now the ESC has updated its model and the new model is much better in that it predicts both fatal and nonfatal events, and the predicted risk correlates well with the actual risk. So that’s a big step forward. However, the new thresholds for statin treatment are far too high for low-risk European countries because very few individuals will now qualify for statin therapy,” he said.

“The problem is that, if we use these guidelines, the vast majority of those individuals who will develop cardiovascular disease within 10 years will not be assigned statin therapy that can reduce this risk. There will be lots of individuals who are at high risk of cardiovascular disease, but these guidelines will not identify them as needing to take a statin,” Dr. Mortensen commented.

“If we use the U.K. or U.S. guidelines, far more people in these low-risk European countries would be eligible for statin therapy and we would prevent far more events than if we use the new ESC guidelines,” he added.

Dr. Mortensen explained that the problem arises from having four different risk score models in Europe for areas at different risk, but they all use the same risk thresholds for statin treatment.

“In general, Eastern European countries have higher risk than Western European countries, so these guidelines may work quite well in Eastern European countries but in low-risk Western European countries, where the low-risk score model is used, very few people will qualify for statin therapy,” he said.

While Dr. Mortensen is not against the idea of different risk models in areas that have different risks, he says this needs to be accompanied by different risk thresholds in the different risk areas.

Asked whether there is an argument that most individuals in low-risk countries may not need to take a statin, Dr. Mortensen countered: “One of the reasons the risk is low in many of these European countries is the high use of preventative medication. So, if a threshold that is too high is used most people will not take a statin anymore and the risk in these countries will increase again.”

Authors of the accompanying editorial, Ann Marie Navar, MD, PhD, University of Texas Southwestern Medical Center, Dallas; Gregg C. Fonarow, MD, University of California, Los Angeles; and Michael J. Pencina, PhD, Duke University Medical Center, Durham, N.C., agreed with Dr. Mortensen that the problems appear to arise from use of a risk score that is highly influenced by regional cardiovascular burden.

They point out that under the current guidelines, a 55-year-old woman (smoker; systolic blood pressure, 130 mm Hg; non–HDL cholesterol, 4.0 mmol/L) would have a 10-year predicted risk of having a cardiovascular event of 5% in Denmark but a predicted risk of 18% in Romania.

“While there may be regional differences in environmental risk factors, location alone should not cause a fourfold difference in an individual’s predicted cardiovascular risk,” they wrote.

The editorialists also elaborated on Dr. Mortensen’s point that the new guideline creates a system that eventually becomes a victim of its own success.

“As countries are successful in implementing statin therapy to lower CVD, CVD rates drop, and progressively fewer individuals are then eligible for the very therapy that contributed to the decline in CVD in the first place,” they noted.

The editorialists called for the analysis to be replicated in other low-risk countries and extended to higher-risk regions, with a focus on potential overtreatment of men and older adults.

“If confirmed, the present findings should be a catalyst for the ESC to revisit or augment their current guidelines to prevent a step backward in the use of statins in primary prevention,” they concluded.

This news organization asked the ESC for a response to the findings, but did not comment by press time.

This work was supported by the Lundbeck Foundation, Herlev and Gentofte Hospital, Copenhagen University Hospital, the Copenhagen County Foundation, and Aarhus University, Denmark. Dr. Mortensen reported no disclosures.

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