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BA.4 and BA.5 subvariants are more evasive of antibodies, but not of cellular immunity
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. 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. 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. 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.
High residual liver cancer risk in HCV-cured cirrhosis
A new study confirms the very high risk of hepatocellular carcinoma faced by patients with cirrhosis who have been cured of hepatitis C, a finding the researchers hope will encourage clinicians to communicate risk information to patients and encourage regular HCC screening.
On average, the predicted probability of HCC in cirrhosis patients was 410 times greater than the equivalent probability in the general population, the study team found.
Hamish Innes, PhD, with Public Health Scotland, Glasgow, and colleagues wrote.
“Central to this is ensuring that cured cirrhosis patients understand the risk of HCC and are provided with appropriate surveillance,” they added.
“Most patients with cirrhosis do not adhere to HCC screening guidelines,” Nina Beri, MD, medical oncologist with New York University Perlmutter Cancer Center, who wasn’t involved in the study, said in an interview.
The “important” finding in this study “should be conveyed to patients, as this may help improve screening adherence rates,” Dr. Beri said.
The study was published online in the American Journal of Gastroenterology.
Findings may help promote screening uptake
Dr. Innes and colleagues compared the predicted probability of HCC in 1,803 Scottish adults (mean age, 50 years; 74% male) with cirrhosis and cured hepatitis C to the background risk in the general population of Scotland.
The mean predicted 3-year probability of HCC at the time of sustained viral response (SVR), determined using the aMAP prognostic model, was 3.64% (range, 0.012%-36.12%).
This contrasts with a 3-year HCC probability in the general population ranging from less than 0.0001% to 0.25% depending on demographics.
All patients with cirrhosis – even those at lowest risk – had a higher probability of HCC than the general population, but there was considerable heterogeneity from one patient to the next.
For example, the mean 3-year predicted probability was 18 times higher in the top quintile (9.8%) versus the lowest quintile (0.5%) of risk, the researchers found.
They could not identify a patient subgroup who exhibited a similar HCC risk profile to the general population, as was their hope going into the study.
Dr. Innes and colleagues have developed an online tool that allows clinicians to frame a patient›s 3-year HCC probability against the equivalent probability in the general population.
In the future, they said the scope of the tool could be extended by incorporating general population data from countries beyond Scotland.
“Our hope is that this tool will springboard patient-clinician discussions about HCC risk, and could mitigate low screening uptake,” Dr. Innes and colleagues wrote.
Curing HCV doesn’t eliminate risk
Commenting on the study, Nancy Reau, MD, section chief of hepatology at Rush University Medical Center, Chicago, said curing HCV is “very important and significantly reduces risk for complications, but it doesn’t return you to the normal population.”
Dr. Reau’s advice to cirrhosis patients: “Get screened twice a year.”
Dr. Beri said, in addition to conveying this risk to patients, “it is also important to disseminate this information to the community and to primary care practices, particularly as some patients may not currently follow in a specialized liver disease clinic.”
Also weighing in, Amit Singal, MD, chief of hepatology at the University of Texas Southwestern Medical Center, Dallas, said this study highlights that underlying cirrhosis is “the strongest risk factor for the development of HCC.”
In contrast to other cancers, such as breast and colorectal cancer, in which high risk populations can be identified by readily available information such as age and sex, implementation of HCC screening programs requires identification of patients with cirrhosis, Dr. Singal noted.
“Underuse of HCC screening in clinical practice is often related to providers having difficulty at this step in the process and contributes to the high proportion of HCC detected at late stages,” he told this news organization.
“Availability of accurate noninvasive markers of fibrosis will hopefully help with better identification of patients with cirrhosis moving forward,” Dr. Singal said, “although we as hepatologists need to work closely with our primary care colleagues to ensure these tools are used routinely in at-risk patients, such as those with nonalcoholic fatty liver disease, alcohol-associated liver disease, or history of cured (post-SVR) hepatitis C infection.”
The study was supported by the Medical Research Foundation and Public Health Scotland. Dr. Innes, Dr. Beri, Dr. Reau, and Dr. Singal reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A new study confirms the very high risk of hepatocellular carcinoma faced by patients with cirrhosis who have been cured of hepatitis C, a finding the researchers hope will encourage clinicians to communicate risk information to patients and encourage regular HCC screening.
On average, the predicted probability of HCC in cirrhosis patients was 410 times greater than the equivalent probability in the general population, the study team found.
Hamish Innes, PhD, with Public Health Scotland, Glasgow, and colleagues wrote.
“Central to this is ensuring that cured cirrhosis patients understand the risk of HCC and are provided with appropriate surveillance,” they added.
“Most patients with cirrhosis do not adhere to HCC screening guidelines,” Nina Beri, MD, medical oncologist with New York University Perlmutter Cancer Center, who wasn’t involved in the study, said in an interview.
The “important” finding in this study “should be conveyed to patients, as this may help improve screening adherence rates,” Dr. Beri said.
The study was published online in the American Journal of Gastroenterology.
Findings may help promote screening uptake
Dr. Innes and colleagues compared the predicted probability of HCC in 1,803 Scottish adults (mean age, 50 years; 74% male) with cirrhosis and cured hepatitis C to the background risk in the general population of Scotland.
The mean predicted 3-year probability of HCC at the time of sustained viral response (SVR), determined using the aMAP prognostic model, was 3.64% (range, 0.012%-36.12%).
This contrasts with a 3-year HCC probability in the general population ranging from less than 0.0001% to 0.25% depending on demographics.
All patients with cirrhosis – even those at lowest risk – had a higher probability of HCC than the general population, but there was considerable heterogeneity from one patient to the next.
For example, the mean 3-year predicted probability was 18 times higher in the top quintile (9.8%) versus the lowest quintile (0.5%) of risk, the researchers found.
They could not identify a patient subgroup who exhibited a similar HCC risk profile to the general population, as was their hope going into the study.
Dr. Innes and colleagues have developed an online tool that allows clinicians to frame a patient›s 3-year HCC probability against the equivalent probability in the general population.
In the future, they said the scope of the tool could be extended by incorporating general population data from countries beyond Scotland.
“Our hope is that this tool will springboard patient-clinician discussions about HCC risk, and could mitigate low screening uptake,” Dr. Innes and colleagues wrote.
Curing HCV doesn’t eliminate risk
Commenting on the study, Nancy Reau, MD, section chief of hepatology at Rush University Medical Center, Chicago, said curing HCV is “very important and significantly reduces risk for complications, but it doesn’t return you to the normal population.”
Dr. Reau’s advice to cirrhosis patients: “Get screened twice a year.”
Dr. Beri said, in addition to conveying this risk to patients, “it is also important to disseminate this information to the community and to primary care practices, particularly as some patients may not currently follow in a specialized liver disease clinic.”
Also weighing in, Amit Singal, MD, chief of hepatology at the University of Texas Southwestern Medical Center, Dallas, said this study highlights that underlying cirrhosis is “the strongest risk factor for the development of HCC.”
In contrast to other cancers, such as breast and colorectal cancer, in which high risk populations can be identified by readily available information such as age and sex, implementation of HCC screening programs requires identification of patients with cirrhosis, Dr. Singal noted.
“Underuse of HCC screening in clinical practice is often related to providers having difficulty at this step in the process and contributes to the high proportion of HCC detected at late stages,” he told this news organization.
“Availability of accurate noninvasive markers of fibrosis will hopefully help with better identification of patients with cirrhosis moving forward,” Dr. Singal said, “although we as hepatologists need to work closely with our primary care colleagues to ensure these tools are used routinely in at-risk patients, such as those with nonalcoholic fatty liver disease, alcohol-associated liver disease, or history of cured (post-SVR) hepatitis C infection.”
The study was supported by the Medical Research Foundation and Public Health Scotland. Dr. Innes, Dr. Beri, Dr. Reau, and Dr. Singal reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A new study confirms the very high risk of hepatocellular carcinoma faced by patients with cirrhosis who have been cured of hepatitis C, a finding the researchers hope will encourage clinicians to communicate risk information to patients and encourage regular HCC screening.
On average, the predicted probability of HCC in cirrhosis patients was 410 times greater than the equivalent probability in the general population, the study team found.
Hamish Innes, PhD, with Public Health Scotland, Glasgow, and colleagues wrote.
“Central to this is ensuring that cured cirrhosis patients understand the risk of HCC and are provided with appropriate surveillance,” they added.
“Most patients with cirrhosis do not adhere to HCC screening guidelines,” Nina Beri, MD, medical oncologist with New York University Perlmutter Cancer Center, who wasn’t involved in the study, said in an interview.
The “important” finding in this study “should be conveyed to patients, as this may help improve screening adherence rates,” Dr. Beri said.
The study was published online in the American Journal of Gastroenterology.
Findings may help promote screening uptake
Dr. Innes and colleagues compared the predicted probability of HCC in 1,803 Scottish adults (mean age, 50 years; 74% male) with cirrhosis and cured hepatitis C to the background risk in the general population of Scotland.
The mean predicted 3-year probability of HCC at the time of sustained viral response (SVR), determined using the aMAP prognostic model, was 3.64% (range, 0.012%-36.12%).
This contrasts with a 3-year HCC probability in the general population ranging from less than 0.0001% to 0.25% depending on demographics.
All patients with cirrhosis – even those at lowest risk – had a higher probability of HCC than the general population, but there was considerable heterogeneity from one patient to the next.
For example, the mean 3-year predicted probability was 18 times higher in the top quintile (9.8%) versus the lowest quintile (0.5%) of risk, the researchers found.
They could not identify a patient subgroup who exhibited a similar HCC risk profile to the general population, as was their hope going into the study.
Dr. Innes and colleagues have developed an online tool that allows clinicians to frame a patient›s 3-year HCC probability against the equivalent probability in the general population.
In the future, they said the scope of the tool could be extended by incorporating general population data from countries beyond Scotland.
“Our hope is that this tool will springboard patient-clinician discussions about HCC risk, and could mitigate low screening uptake,” Dr. Innes and colleagues wrote.
Curing HCV doesn’t eliminate risk
Commenting on the study, Nancy Reau, MD, section chief of hepatology at Rush University Medical Center, Chicago, said curing HCV is “very important and significantly reduces risk for complications, but it doesn’t return you to the normal population.”
Dr. Reau’s advice to cirrhosis patients: “Get screened twice a year.”
Dr. Beri said, in addition to conveying this risk to patients, “it is also important to disseminate this information to the community and to primary care practices, particularly as some patients may not currently follow in a specialized liver disease clinic.”
Also weighing in, Amit Singal, MD, chief of hepatology at the University of Texas Southwestern Medical Center, Dallas, said this study highlights that underlying cirrhosis is “the strongest risk factor for the development of HCC.”
In contrast to other cancers, such as breast and colorectal cancer, in which high risk populations can be identified by readily available information such as age and sex, implementation of HCC screening programs requires identification of patients with cirrhosis, Dr. Singal noted.
“Underuse of HCC screening in clinical practice is often related to providers having difficulty at this step in the process and contributes to the high proportion of HCC detected at late stages,” he told this news organization.
“Availability of accurate noninvasive markers of fibrosis will hopefully help with better identification of patients with cirrhosis moving forward,” Dr. Singal said, “although we as hepatologists need to work closely with our primary care colleagues to ensure these tools are used routinely in at-risk patients, such as those with nonalcoholic fatty liver disease, alcohol-associated liver disease, or history of cured (post-SVR) hepatitis C infection.”
The study was supported by the Medical Research Foundation and Public Health Scotland. Dr. Innes, Dr. Beri, Dr. Reau, and Dr. Singal reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE AMERICAN JOURNAL OF GASTROENTEROLOGY
Obesity links to faster fading of COVID vaccine protection
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
- 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
- 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
- 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.
Liver disease and death rates fall after hepatitis C treatment barriers are dismantled
As obstacles to hepatitis C treatment uptake were removed, rates of hepatitis-related liver disease in marginalized groups plummeted, according to a new study in Baltimore, published in Annals of Internal Medicine.
A community-based cohort study that follows current and former people who inject drugs (PWID) with hepatitis C documented drastic reductions in liver disease and death as effective oral antivirals became more readily accessible there between 2015 and 2019.
The researchers concluded that hepatitis C elimination targets are achievable. But, they warned, uptake is uneven, and more needs to be done to facilitate treatment.
“[The study] gives us a real-world perspective on what’s happening on the ground, in terms of people getting treated,” said first author Javier Cepeda, PhD, MPH, an assistant professor at the Johns Hopkins Bloomberg School of Public Health, Baltimore, in an interview. “Changing policy, reducing barriers, [and] getting them access to treatment really does have this really important public health benefit.”
” said Maria Corcorran, MD, MPH. Dr. Corcorran, an acting assistant professor for the department of medicine at the University of Washington, was not involved with the study. “It’s just further evidence that we need to really be linking people to care and getting people treated and cured.”
The World Health Organization has called for the disease’s global elimination by 2030. Cure rates top 95%. But, there are so many new cases and so many barriers to detection and treatment that how to develop and roll out a public health response is the most important question in the field, wrote study co-author David L. Thomas, MD, MPH, in a review article in The New England Journal of Medicine.
“Folks who inject drugs ... do well on hep C treatment and have similar rates of sustained virologic response or cure,” said Dr. Corcorran, who runs a low-barrier clinic for people experiencing homelessness.
But, she added, “there are barriers that are still put up to treatment in terms of who can treat and what insurance is going to cover.”
A look at a vulnerable population
The authors studied adults enrolled in ALIVE (AIDS Linked to the Intravenous Experience), a cohort study that has recruited current and former PWID in the Baltimore area since 1988.
Participants visit the clinic twice a year for health-related interviews and blood testing, including HIV serology, hepatitis C virus (HCV) antibody and RNA testing, and liver function tests. They are counseled about HCV testing and treatment but do not receive treatment through the study.
Beginning in 2006, researchers added liver stiffness measures (LSMs), a noninvasive measure conducted with transient elastography.
From 2006 to 2019, the authors followed 1,323 ALIVE participants with chronic HCV infection. The primary outcome was LSMs.
Less liver disease, fewer deaths
At baseline, participants’ median age was 49 years; 82% of participants were Black individuals, 71% percent were male, and two-thirds were HIV-negative.
Three percent reported receiving hepatitis C treatment in 2014, which increased to 39% in 2019.
Among 10,350 LSMs, 15% showed cirrhosis at baseline in 2006. In 2015, that rose to 19%, but by 2019, it had fallen to 8%.
By definition, 100% had detectable HCV RNA at baseline. In 2015, 91% still did. By 2019, that rate had fallen to 48%.
Undetectable HCV RNA correlated with lower log LSM in adjusted models (P < .001). It also correlated strongly with lower odds of liver cirrhosis, with an adjusted odds ratio of 0.28 (95% confidence interval, 0.17-0.45; P < .001). In addition, it correlated with lower risk for all-cause mortality, with an adjusted hazard ratio of 0.54 (95% CI, 0.38-0.77; P < .001).
Limitations include the fact that, although transient elastography is considered the most valid way to detect cirrhosis in people with hepatitis C, liver stiffness has not been validated as a measure of fibrosis among people with a sustained virologic response.
In addition, ALIVE participants are older and more likely to be African American individuals, compared with the general population of PWID in Baltimore, wrote co-author Shruti H. Mehta, PhD, a professor of epidemiology at Johns Hopkins University, Baltimore, in an email exchange with this news organization. That could affect generalizability.
Treatment is crucial
The first direct-acting antiviral (DAA) for hepatitis C was approved in 2011, and an oral fixed-dose combination antiviral was approved in 2014, ushering in treatments with cure rates far exceeding those with interferon-based therapy.
But until recently, Medicaid patients in Maryland seeking DAA therapy for hepatitis C required prior authorization, with initial restrictions related to disease stage, substance use, and provider type, according to Dr. Mehta.
Gradually, those restrictions were lifted, Dr. Mehta added, and all were eliminated by 2019.
Dr. Cepeda urges clinicians to treat patients infected with hepatitis C immediately.
“There are really important implications on both reducing liver disease progression and all-cause mortality,” he said.
“Hep C is just one part of a whole constellation of health care delivery [and] of treating all of the other potential problems that might need to be addressed – especially with people who inject drugs,” Dr. Cepeda added. “Getting them into care is really, really important.”
The study was funded by the National Institutes of Health. Dr. Cepeda and Dr. Corcorran report no relevant financial relationships. Dr. Mehta reports receiving payments or honoraria and travel support from Gilead Sciences, the makers of the oral hepatitis C medication ledipasvir/sofosbuvir (Harvoni), as well as equipment, materials, drugs, medical writing, gifts, or other services from Abbott, which sells hepatitis C diagnostics. Dr. Thomas reports ties to Excision Bio and to Merck DSMB.
A version of this article first appeared on Medscape.com.
As obstacles to hepatitis C treatment uptake were removed, rates of hepatitis-related liver disease in marginalized groups plummeted, according to a new study in Baltimore, published in Annals of Internal Medicine.
A community-based cohort study that follows current and former people who inject drugs (PWID) with hepatitis C documented drastic reductions in liver disease and death as effective oral antivirals became more readily accessible there between 2015 and 2019.
The researchers concluded that hepatitis C elimination targets are achievable. But, they warned, uptake is uneven, and more needs to be done to facilitate treatment.
“[The study] gives us a real-world perspective on what’s happening on the ground, in terms of people getting treated,” said first author Javier Cepeda, PhD, MPH, an assistant professor at the Johns Hopkins Bloomberg School of Public Health, Baltimore, in an interview. “Changing policy, reducing barriers, [and] getting them access to treatment really does have this really important public health benefit.”
” said Maria Corcorran, MD, MPH. Dr. Corcorran, an acting assistant professor for the department of medicine at the University of Washington, was not involved with the study. “It’s just further evidence that we need to really be linking people to care and getting people treated and cured.”
The World Health Organization has called for the disease’s global elimination by 2030. Cure rates top 95%. But, there are so many new cases and so many barriers to detection and treatment that how to develop and roll out a public health response is the most important question in the field, wrote study co-author David L. Thomas, MD, MPH, in a review article in The New England Journal of Medicine.
“Folks who inject drugs ... do well on hep C treatment and have similar rates of sustained virologic response or cure,” said Dr. Corcorran, who runs a low-barrier clinic for people experiencing homelessness.
But, she added, “there are barriers that are still put up to treatment in terms of who can treat and what insurance is going to cover.”
A look at a vulnerable population
The authors studied adults enrolled in ALIVE (AIDS Linked to the Intravenous Experience), a cohort study that has recruited current and former PWID in the Baltimore area since 1988.
Participants visit the clinic twice a year for health-related interviews and blood testing, including HIV serology, hepatitis C virus (HCV) antibody and RNA testing, and liver function tests. They are counseled about HCV testing and treatment but do not receive treatment through the study.
Beginning in 2006, researchers added liver stiffness measures (LSMs), a noninvasive measure conducted with transient elastography.
From 2006 to 2019, the authors followed 1,323 ALIVE participants with chronic HCV infection. The primary outcome was LSMs.
Less liver disease, fewer deaths
At baseline, participants’ median age was 49 years; 82% of participants were Black individuals, 71% percent were male, and two-thirds were HIV-negative.
Three percent reported receiving hepatitis C treatment in 2014, which increased to 39% in 2019.
Among 10,350 LSMs, 15% showed cirrhosis at baseline in 2006. In 2015, that rose to 19%, but by 2019, it had fallen to 8%.
By definition, 100% had detectable HCV RNA at baseline. In 2015, 91% still did. By 2019, that rate had fallen to 48%.
Undetectable HCV RNA correlated with lower log LSM in adjusted models (P < .001). It also correlated strongly with lower odds of liver cirrhosis, with an adjusted odds ratio of 0.28 (95% confidence interval, 0.17-0.45; P < .001). In addition, it correlated with lower risk for all-cause mortality, with an adjusted hazard ratio of 0.54 (95% CI, 0.38-0.77; P < .001).
Limitations include the fact that, although transient elastography is considered the most valid way to detect cirrhosis in people with hepatitis C, liver stiffness has not been validated as a measure of fibrosis among people with a sustained virologic response.
In addition, ALIVE participants are older and more likely to be African American individuals, compared with the general population of PWID in Baltimore, wrote co-author Shruti H. Mehta, PhD, a professor of epidemiology at Johns Hopkins University, Baltimore, in an email exchange with this news organization. That could affect generalizability.
Treatment is crucial
The first direct-acting antiviral (DAA) for hepatitis C was approved in 2011, and an oral fixed-dose combination antiviral was approved in 2014, ushering in treatments with cure rates far exceeding those with interferon-based therapy.
But until recently, Medicaid patients in Maryland seeking DAA therapy for hepatitis C required prior authorization, with initial restrictions related to disease stage, substance use, and provider type, according to Dr. Mehta.
Gradually, those restrictions were lifted, Dr. Mehta added, and all were eliminated by 2019.
Dr. Cepeda urges clinicians to treat patients infected with hepatitis C immediately.
“There are really important implications on both reducing liver disease progression and all-cause mortality,” he said.
“Hep C is just one part of a whole constellation of health care delivery [and] of treating all of the other potential problems that might need to be addressed – especially with people who inject drugs,” Dr. Cepeda added. “Getting them into care is really, really important.”
The study was funded by the National Institutes of Health. Dr. Cepeda and Dr. Corcorran report no relevant financial relationships. Dr. Mehta reports receiving payments or honoraria and travel support from Gilead Sciences, the makers of the oral hepatitis C medication ledipasvir/sofosbuvir (Harvoni), as well as equipment, materials, drugs, medical writing, gifts, or other services from Abbott, which sells hepatitis C diagnostics. Dr. Thomas reports ties to Excision Bio and to Merck DSMB.
A version of this article first appeared on Medscape.com.
As obstacles to hepatitis C treatment uptake were removed, rates of hepatitis-related liver disease in marginalized groups plummeted, according to a new study in Baltimore, published in Annals of Internal Medicine.
A community-based cohort study that follows current and former people who inject drugs (PWID) with hepatitis C documented drastic reductions in liver disease and death as effective oral antivirals became more readily accessible there between 2015 and 2019.
The researchers concluded that hepatitis C elimination targets are achievable. But, they warned, uptake is uneven, and more needs to be done to facilitate treatment.
“[The study] gives us a real-world perspective on what’s happening on the ground, in terms of people getting treated,” said first author Javier Cepeda, PhD, MPH, an assistant professor at the Johns Hopkins Bloomberg School of Public Health, Baltimore, in an interview. “Changing policy, reducing barriers, [and] getting them access to treatment really does have this really important public health benefit.”
” said Maria Corcorran, MD, MPH. Dr. Corcorran, an acting assistant professor for the department of medicine at the University of Washington, was not involved with the study. “It’s just further evidence that we need to really be linking people to care and getting people treated and cured.”
The World Health Organization has called for the disease’s global elimination by 2030. Cure rates top 95%. But, there are so many new cases and so many barriers to detection and treatment that how to develop and roll out a public health response is the most important question in the field, wrote study co-author David L. Thomas, MD, MPH, in a review article in The New England Journal of Medicine.
“Folks who inject drugs ... do well on hep C treatment and have similar rates of sustained virologic response or cure,” said Dr. Corcorran, who runs a low-barrier clinic for people experiencing homelessness.
But, she added, “there are barriers that are still put up to treatment in terms of who can treat and what insurance is going to cover.”
A look at a vulnerable population
The authors studied adults enrolled in ALIVE (AIDS Linked to the Intravenous Experience), a cohort study that has recruited current and former PWID in the Baltimore area since 1988.
Participants visit the clinic twice a year for health-related interviews and blood testing, including HIV serology, hepatitis C virus (HCV) antibody and RNA testing, and liver function tests. They are counseled about HCV testing and treatment but do not receive treatment through the study.
Beginning in 2006, researchers added liver stiffness measures (LSMs), a noninvasive measure conducted with transient elastography.
From 2006 to 2019, the authors followed 1,323 ALIVE participants with chronic HCV infection. The primary outcome was LSMs.
Less liver disease, fewer deaths
At baseline, participants’ median age was 49 years; 82% of participants were Black individuals, 71% percent were male, and two-thirds were HIV-negative.
Three percent reported receiving hepatitis C treatment in 2014, which increased to 39% in 2019.
Among 10,350 LSMs, 15% showed cirrhosis at baseline in 2006. In 2015, that rose to 19%, but by 2019, it had fallen to 8%.
By definition, 100% had detectable HCV RNA at baseline. In 2015, 91% still did. By 2019, that rate had fallen to 48%.
Undetectable HCV RNA correlated with lower log LSM in adjusted models (P < .001). It also correlated strongly with lower odds of liver cirrhosis, with an adjusted odds ratio of 0.28 (95% confidence interval, 0.17-0.45; P < .001). In addition, it correlated with lower risk for all-cause mortality, with an adjusted hazard ratio of 0.54 (95% CI, 0.38-0.77; P < .001).
Limitations include the fact that, although transient elastography is considered the most valid way to detect cirrhosis in people with hepatitis C, liver stiffness has not been validated as a measure of fibrosis among people with a sustained virologic response.
In addition, ALIVE participants are older and more likely to be African American individuals, compared with the general population of PWID in Baltimore, wrote co-author Shruti H. Mehta, PhD, a professor of epidemiology at Johns Hopkins University, Baltimore, in an email exchange with this news organization. That could affect generalizability.
Treatment is crucial
The first direct-acting antiviral (DAA) for hepatitis C was approved in 2011, and an oral fixed-dose combination antiviral was approved in 2014, ushering in treatments with cure rates far exceeding those with interferon-based therapy.
But until recently, Medicaid patients in Maryland seeking DAA therapy for hepatitis C required prior authorization, with initial restrictions related to disease stage, substance use, and provider type, according to Dr. Mehta.
Gradually, those restrictions were lifted, Dr. Mehta added, and all were eliminated by 2019.
Dr. Cepeda urges clinicians to treat patients infected with hepatitis C immediately.
“There are really important implications on both reducing liver disease progression and all-cause mortality,” he said.
“Hep C is just one part of a whole constellation of health care delivery [and] of treating all of the other potential problems that might need to be addressed – especially with people who inject drugs,” Dr. Cepeda added. “Getting them into care is really, really important.”
The study was funded by the National Institutes of Health. Dr. Cepeda and Dr. Corcorran report no relevant financial relationships. Dr. Mehta reports receiving payments or honoraria and travel support from Gilead Sciences, the makers of the oral hepatitis C medication ledipasvir/sofosbuvir (Harvoni), as well as equipment, materials, drugs, medical writing, gifts, or other services from Abbott, which sells hepatitis C diagnostics. Dr. Thomas reports ties to Excision Bio and to Merck DSMB.
A version of this article first appeared on Medscape.com.
Long COVID-19 in children and adolescents: What do we know?
Among scientists, the existence of long COVID-19 in children and adolescents has been the subject of debate.
Published by a Mexican multidisciplinary group in Scientific Reports, the first study is a systematic review and meta-analysis. It identified mood symptoms as the most prevalent clinical manifestations of long COVID-19 in children and adolescents. These symptoms included sadness, tension, anger, depression, and anxiety (16.50%); fatigue (9.66%); and sleep disorders (8.42%).
The second study, LongCOVIDKidsDK, was conducted in Denmark. It compared 11,000 children younger than 14 years who had tested positive for COVID-19 with 33,000 children who had no history of COVID-19. The study was published in The Lancet Child and Adolescent Health.
Definitions are changing
In their meta-analysis, the researchers estimated the prevalence and counted signs and symptoms of long COVID-19, as defined by the United Kingdom’s National Institute for Health and Care Excellence. Long COVID-19 was defined as the presence of one or more symptoms more than 4 weeks after SARS-CoV-2 infection. For search terms, the researchers used “COVID-19,” “COVID,” “SARSCOV-2,” “coronavirus,” “long COVID,” “postCOVID,” “PASC,” “long-haulers,” “prolonged,” “post-acute,” “persistent,” “convalescent,” “sequelae,” and “postviral.”
Of the 8,373 citations returned by the search as of Feb. 10, 2022, 21 prospective studies, 2 of them on preprint servers, met the authors’ selection criteria. Those studies included a total of 80,071 children and adolescents younger than 18 years.
In the meta-analysis, the prevalence of long COVID-19 among children and adolescents was reported to be 25.24% (95% confidence interval, 18.17-33.02; I2, 99.61%), regardless of whether the case had been asymptomatic, mild, moderate, severe, or serious. For patients who had been hospitalized, the prevalence was 29.19% (95% CI, 17.83-41.98; I2, 80.84%).
These numbers, while striking, are not the focus of the study, according to first author Sandra Lopez-Leon, MD, PhD, associate professor of pharmacoepidemiology at Rutgers University, New Brunswick, N.J. “It’s important that we don’t focus on that 25%,” she said in an interview. “It’s a disease that we’re learning about, we’re at a time when the definitions are still changing, and, depending on when it is measured, a different number will be given. The message we want to give is that long COVID-19 exists, it’s happening in children and adolescents, and patients need this recognition. And also to show that it can affect the whole body.”
The study showed that the children and adolescents who presented with SARS-CoV-2 infection were at higher risk of subsequent long dyspnea, anosmia/ageusia, or fever, compared with control persons.
In total, in the studies that were included, more than 40 long-term clinical manifestations associated with COVID-19 in the pediatric population were identified.
The most common symptoms among children aged 0-3 years were mood swings, skin rashes, and stomachaches. In 4- to 11-year-olds, the most common symptoms were mood swings, trouble remembering or concentrating, and skin rashes. In 12- to 14-year-olds, they were fatigue, mood swings, and trouble remembering or concentrating. These data are based on parent responses.
The list of signs and symptoms also includes headache, respiratory symptoms, cognitive symptoms (such as decreased concentration, learning difficulties, confusion, and memory loss), loss of appetite, and smell disorder (hyposmia, anosmia, hyperosmia, parosmia, and phantom smell).
In the studies, the prevalence of the following symptoms was less than 5%: hyperhidrosis, chest pain, dizziness, cough, myalgia/arthralgia, changes in body weight, taste disorder, otalgia (tinnitus, ear pain, vertigo), ophthalmologic symptoms (conjunctivitis, dry eye, blurred vision, photophobia, pain), dermatologic symptoms (dry skin, itchy skin, rashes, hives, hair loss), urinary symptoms, abdominal pain, throat pain, chest tightness, variations in heart rate, palpitations, constipation, dysphonia, fever, diarrhea, vomiting/nausea, menstrual changes, neurological abnormalities, speech disorders, and dysphagia.
The authors made it clear that the frequency and severity of these symptoms can fluctuate from one patient to another.
“The meta-analysis is important because it brings together 21 studies selected from more than 8,000 articles – and in them, a large number of children – to study the most common manifestations of long COVID-19,” Gabriela Ensinck, MD, head of the infectious diseases department at the Víctor J. Vilela Children’s Hospital in Rosario, Argentina, told this news organization. Dr. Ensinck did not participate in the study. “The important thing here is that long COVID-19 exists in pediatrics. And that it is a prolongation of signs or symptoms over time, a time for which there is no single definition.”
“It’s a snapshot of all the symptoms that can remain after COVID-19,” Dr. Lopez-Leon explained. “The meta-analysis seeks to see if there’s an association between having had COVID-19 and having the symptoms, but at no time does it speak of causality.”
The prevalence of symptoms largely depends on the time since the onset of acute COVID-19. Most symptoms improve over time. In the studies that were included in the meta-analysis, the follow-up time varied between 1 and 13 months. It is important to understand what symptoms are associated with each period after the onset of infection, the authors said.
Danish parent survey
The Danish study LongCOVIDKidsDK followed the World Health Organization criteria for long COVID-19 and included children and adolescents aged 0-14 years who received a diagnosis of COVID-19 and who experienced symptoms that lasted at least 2 months.
Between July 20, 2021, and Sept. 15, 2021, a questionnaire was sent to 38,152 case patients and 147,212 control persons. Of this group, 10,997 (28.8%) case patients and 33,016 (22.4%) control persons answered the survey.
Children who had been diagnosed with SARS-CoV-2 infection were more likely to experience long-lasting symptoms than children who had never been diagnosed. Approximately one-third of children with a positive SARS-CoV-2 test experienced symptoms that were not present before infection. Children who experienced long-lasting symptoms included 40% of children diagnosed with COVID-19 and 27% of control persons aged 0-3 years, 38% of case patients and 34% of control persons aged 4-11 years, and 46% of case patients and 41% of control persons aged 12-14 years.
Interestingly, those diagnosed with COVID-19 reported fewer psychological and social problems than those in the control group. Among the oldest (aged 12-14 years), quality of life scores were higher and anxiety scores were lower for those who had tested positive for SARS-CoV-2.
More information needed
Given the diversity of symptoms in the meta-analysis and the LongCOVIDKidsDK study, a multidisciplinary approach is imperative. Dr. Lopez-Leon suggests that there is a need to raise awareness among parents, clinicians, researchers, and the health system about the conditions that can occur after COVID-19. Clinicians must better understand the sequelae to provide targeted care and treatment. The authors of the Danish study recommend establishing clinics for long COVID-19 with multispecialty care.
Maren J. Heilskov Rytter, PhD, associate professor of clinical medicine at the University of Copenhagen, wrote an editorial in The Lancet Child and Adolescent Health about the Danish study. Until it is clarified whether SARS-CoV-2 does indeed cause persistent symptoms, she wrote, “it seems excessive and premature to establish specific multidisciplinary clinics for children with long COVID-19.”
Dr. Rytter highlighted the difficulty of interpreting LongCOVIDKidsDK data, owing to recall bias, the failure to exclude other causes of symptoms in the cases analyzed, and the number of symptoms in the control persons. In addition, the data analyzed in Denmark are of limited clinical relevance, she said, given a greater presence of mild symptoms and, paradoxically, a higher quality of life.
She concluded, “In the majority of children with nonspecific symptoms after COVID-19, the symptoms presented are more likely to have been caused by something other than COVID-19, and if they are related to COVID-19, they are likely to go away over time.”
Dr. Ensinck, who is coauthor of the Argentine Ministry of Health’s guide for long COVID-19 monitoring for children and adolescents and who represented the Infectious Diseases Committee of the Argentine Society of Pediatrics, highlighted another aspect of the problem. “What should be taken into account in these data is to see how much the confinement contributed. Children are the ones who suffered the most in the period in which schools were closed; they could not meet their peers, they had sick relatives, they felt fear. … all this must be taken into account.”
There is as yet no agreement on how to define and diagnose long COVID-19 in adults, a population that has been studied more closely. Part of the problem is that long COVID-19 has been linked to more than 200 symptoms, which can range in severity from inconvenient to debilitating, can last for months or years, and can recur, sometimes months after apparent recovery. Thus, there are still disparate answers to basic questions about the syndrome’s frequency and its effects on vaccination, reinfection, and the latest variant of SARS-CoV-2.
This article has been translated from the Medscape Spanish edition. A version appeared on Medscape.com.
Among scientists, the existence of long COVID-19 in children and adolescents has been the subject of debate.
Published by a Mexican multidisciplinary group in Scientific Reports, the first study is a systematic review and meta-analysis. It identified mood symptoms as the most prevalent clinical manifestations of long COVID-19 in children and adolescents. These symptoms included sadness, tension, anger, depression, and anxiety (16.50%); fatigue (9.66%); and sleep disorders (8.42%).
The second study, LongCOVIDKidsDK, was conducted in Denmark. It compared 11,000 children younger than 14 years who had tested positive for COVID-19 with 33,000 children who had no history of COVID-19. The study was published in The Lancet Child and Adolescent Health.
Definitions are changing
In their meta-analysis, the researchers estimated the prevalence and counted signs and symptoms of long COVID-19, as defined by the United Kingdom’s National Institute for Health and Care Excellence. Long COVID-19 was defined as the presence of one or more symptoms more than 4 weeks after SARS-CoV-2 infection. For search terms, the researchers used “COVID-19,” “COVID,” “SARSCOV-2,” “coronavirus,” “long COVID,” “postCOVID,” “PASC,” “long-haulers,” “prolonged,” “post-acute,” “persistent,” “convalescent,” “sequelae,” and “postviral.”
Of the 8,373 citations returned by the search as of Feb. 10, 2022, 21 prospective studies, 2 of them on preprint servers, met the authors’ selection criteria. Those studies included a total of 80,071 children and adolescents younger than 18 years.
In the meta-analysis, the prevalence of long COVID-19 among children and adolescents was reported to be 25.24% (95% confidence interval, 18.17-33.02; I2, 99.61%), regardless of whether the case had been asymptomatic, mild, moderate, severe, or serious. For patients who had been hospitalized, the prevalence was 29.19% (95% CI, 17.83-41.98; I2, 80.84%).
These numbers, while striking, are not the focus of the study, according to first author Sandra Lopez-Leon, MD, PhD, associate professor of pharmacoepidemiology at Rutgers University, New Brunswick, N.J. “It’s important that we don’t focus on that 25%,” she said in an interview. “It’s a disease that we’re learning about, we’re at a time when the definitions are still changing, and, depending on when it is measured, a different number will be given. The message we want to give is that long COVID-19 exists, it’s happening in children and adolescents, and patients need this recognition. And also to show that it can affect the whole body.”
The study showed that the children and adolescents who presented with SARS-CoV-2 infection were at higher risk of subsequent long dyspnea, anosmia/ageusia, or fever, compared with control persons.
In total, in the studies that were included, more than 40 long-term clinical manifestations associated with COVID-19 in the pediatric population were identified.
The most common symptoms among children aged 0-3 years were mood swings, skin rashes, and stomachaches. In 4- to 11-year-olds, the most common symptoms were mood swings, trouble remembering or concentrating, and skin rashes. In 12- to 14-year-olds, they were fatigue, mood swings, and trouble remembering or concentrating. These data are based on parent responses.
The list of signs and symptoms also includes headache, respiratory symptoms, cognitive symptoms (such as decreased concentration, learning difficulties, confusion, and memory loss), loss of appetite, and smell disorder (hyposmia, anosmia, hyperosmia, parosmia, and phantom smell).
In the studies, the prevalence of the following symptoms was less than 5%: hyperhidrosis, chest pain, dizziness, cough, myalgia/arthralgia, changes in body weight, taste disorder, otalgia (tinnitus, ear pain, vertigo), ophthalmologic symptoms (conjunctivitis, dry eye, blurred vision, photophobia, pain), dermatologic symptoms (dry skin, itchy skin, rashes, hives, hair loss), urinary symptoms, abdominal pain, throat pain, chest tightness, variations in heart rate, palpitations, constipation, dysphonia, fever, diarrhea, vomiting/nausea, menstrual changes, neurological abnormalities, speech disorders, and dysphagia.
The authors made it clear that the frequency and severity of these symptoms can fluctuate from one patient to another.
“The meta-analysis is important because it brings together 21 studies selected from more than 8,000 articles – and in them, a large number of children – to study the most common manifestations of long COVID-19,” Gabriela Ensinck, MD, head of the infectious diseases department at the Víctor J. Vilela Children’s Hospital in Rosario, Argentina, told this news organization. Dr. Ensinck did not participate in the study. “The important thing here is that long COVID-19 exists in pediatrics. And that it is a prolongation of signs or symptoms over time, a time for which there is no single definition.”
“It’s a snapshot of all the symptoms that can remain after COVID-19,” Dr. Lopez-Leon explained. “The meta-analysis seeks to see if there’s an association between having had COVID-19 and having the symptoms, but at no time does it speak of causality.”
The prevalence of symptoms largely depends on the time since the onset of acute COVID-19. Most symptoms improve over time. In the studies that were included in the meta-analysis, the follow-up time varied between 1 and 13 months. It is important to understand what symptoms are associated with each period after the onset of infection, the authors said.
Danish parent survey
The Danish study LongCOVIDKidsDK followed the World Health Organization criteria for long COVID-19 and included children and adolescents aged 0-14 years who received a diagnosis of COVID-19 and who experienced symptoms that lasted at least 2 months.
Between July 20, 2021, and Sept. 15, 2021, a questionnaire was sent to 38,152 case patients and 147,212 control persons. Of this group, 10,997 (28.8%) case patients and 33,016 (22.4%) control persons answered the survey.
Children who had been diagnosed with SARS-CoV-2 infection were more likely to experience long-lasting symptoms than children who had never been diagnosed. Approximately one-third of children with a positive SARS-CoV-2 test experienced symptoms that were not present before infection. Children who experienced long-lasting symptoms included 40% of children diagnosed with COVID-19 and 27% of control persons aged 0-3 years, 38% of case patients and 34% of control persons aged 4-11 years, and 46% of case patients and 41% of control persons aged 12-14 years.
Interestingly, those diagnosed with COVID-19 reported fewer psychological and social problems than those in the control group. Among the oldest (aged 12-14 years), quality of life scores were higher and anxiety scores were lower for those who had tested positive for SARS-CoV-2.
More information needed
Given the diversity of symptoms in the meta-analysis and the LongCOVIDKidsDK study, a multidisciplinary approach is imperative. Dr. Lopez-Leon suggests that there is a need to raise awareness among parents, clinicians, researchers, and the health system about the conditions that can occur after COVID-19. Clinicians must better understand the sequelae to provide targeted care and treatment. The authors of the Danish study recommend establishing clinics for long COVID-19 with multispecialty care.
Maren J. Heilskov Rytter, PhD, associate professor of clinical medicine at the University of Copenhagen, wrote an editorial in The Lancet Child and Adolescent Health about the Danish study. Until it is clarified whether SARS-CoV-2 does indeed cause persistent symptoms, she wrote, “it seems excessive and premature to establish specific multidisciplinary clinics for children with long COVID-19.”
Dr. Rytter highlighted the difficulty of interpreting LongCOVIDKidsDK data, owing to recall bias, the failure to exclude other causes of symptoms in the cases analyzed, and the number of symptoms in the control persons. In addition, the data analyzed in Denmark are of limited clinical relevance, she said, given a greater presence of mild symptoms and, paradoxically, a higher quality of life.
She concluded, “In the majority of children with nonspecific symptoms after COVID-19, the symptoms presented are more likely to have been caused by something other than COVID-19, and if they are related to COVID-19, they are likely to go away over time.”
Dr. Ensinck, who is coauthor of the Argentine Ministry of Health’s guide for long COVID-19 monitoring for children and adolescents and who represented the Infectious Diseases Committee of the Argentine Society of Pediatrics, highlighted another aspect of the problem. “What should be taken into account in these data is to see how much the confinement contributed. Children are the ones who suffered the most in the period in which schools were closed; they could not meet their peers, they had sick relatives, they felt fear. … all this must be taken into account.”
There is as yet no agreement on how to define and diagnose long COVID-19 in adults, a population that has been studied more closely. Part of the problem is that long COVID-19 has been linked to more than 200 symptoms, which can range in severity from inconvenient to debilitating, can last for months or years, and can recur, sometimes months after apparent recovery. Thus, there are still disparate answers to basic questions about the syndrome’s frequency and its effects on vaccination, reinfection, and the latest variant of SARS-CoV-2.
This article has been translated from the Medscape Spanish edition. A version appeared on Medscape.com.
Among scientists, the existence of long COVID-19 in children and adolescents has been the subject of debate.
Published by a Mexican multidisciplinary group in Scientific Reports, the first study is a systematic review and meta-analysis. It identified mood symptoms as the most prevalent clinical manifestations of long COVID-19 in children and adolescents. These symptoms included sadness, tension, anger, depression, and anxiety (16.50%); fatigue (9.66%); and sleep disorders (8.42%).
The second study, LongCOVIDKidsDK, was conducted in Denmark. It compared 11,000 children younger than 14 years who had tested positive for COVID-19 with 33,000 children who had no history of COVID-19. The study was published in The Lancet Child and Adolescent Health.
Definitions are changing
In their meta-analysis, the researchers estimated the prevalence and counted signs and symptoms of long COVID-19, as defined by the United Kingdom’s National Institute for Health and Care Excellence. Long COVID-19 was defined as the presence of one or more symptoms more than 4 weeks after SARS-CoV-2 infection. For search terms, the researchers used “COVID-19,” “COVID,” “SARSCOV-2,” “coronavirus,” “long COVID,” “postCOVID,” “PASC,” “long-haulers,” “prolonged,” “post-acute,” “persistent,” “convalescent,” “sequelae,” and “postviral.”
Of the 8,373 citations returned by the search as of Feb. 10, 2022, 21 prospective studies, 2 of them on preprint servers, met the authors’ selection criteria. Those studies included a total of 80,071 children and adolescents younger than 18 years.
In the meta-analysis, the prevalence of long COVID-19 among children and adolescents was reported to be 25.24% (95% confidence interval, 18.17-33.02; I2, 99.61%), regardless of whether the case had been asymptomatic, mild, moderate, severe, or serious. For patients who had been hospitalized, the prevalence was 29.19% (95% CI, 17.83-41.98; I2, 80.84%).
These numbers, while striking, are not the focus of the study, according to first author Sandra Lopez-Leon, MD, PhD, associate professor of pharmacoepidemiology at Rutgers University, New Brunswick, N.J. “It’s important that we don’t focus on that 25%,” she said in an interview. “It’s a disease that we’re learning about, we’re at a time when the definitions are still changing, and, depending on when it is measured, a different number will be given. The message we want to give is that long COVID-19 exists, it’s happening in children and adolescents, and patients need this recognition. And also to show that it can affect the whole body.”
The study showed that the children and adolescents who presented with SARS-CoV-2 infection were at higher risk of subsequent long dyspnea, anosmia/ageusia, or fever, compared with control persons.
In total, in the studies that were included, more than 40 long-term clinical manifestations associated with COVID-19 in the pediatric population were identified.
The most common symptoms among children aged 0-3 years were mood swings, skin rashes, and stomachaches. In 4- to 11-year-olds, the most common symptoms were mood swings, trouble remembering or concentrating, and skin rashes. In 12- to 14-year-olds, they were fatigue, mood swings, and trouble remembering or concentrating. These data are based on parent responses.
The list of signs and symptoms also includes headache, respiratory symptoms, cognitive symptoms (such as decreased concentration, learning difficulties, confusion, and memory loss), loss of appetite, and smell disorder (hyposmia, anosmia, hyperosmia, parosmia, and phantom smell).
In the studies, the prevalence of the following symptoms was less than 5%: hyperhidrosis, chest pain, dizziness, cough, myalgia/arthralgia, changes in body weight, taste disorder, otalgia (tinnitus, ear pain, vertigo), ophthalmologic symptoms (conjunctivitis, dry eye, blurred vision, photophobia, pain), dermatologic symptoms (dry skin, itchy skin, rashes, hives, hair loss), urinary symptoms, abdominal pain, throat pain, chest tightness, variations in heart rate, palpitations, constipation, dysphonia, fever, diarrhea, vomiting/nausea, menstrual changes, neurological abnormalities, speech disorders, and dysphagia.
The authors made it clear that the frequency and severity of these symptoms can fluctuate from one patient to another.
“The meta-analysis is important because it brings together 21 studies selected from more than 8,000 articles – and in them, a large number of children – to study the most common manifestations of long COVID-19,” Gabriela Ensinck, MD, head of the infectious diseases department at the Víctor J. Vilela Children’s Hospital in Rosario, Argentina, told this news organization. Dr. Ensinck did not participate in the study. “The important thing here is that long COVID-19 exists in pediatrics. And that it is a prolongation of signs or symptoms over time, a time for which there is no single definition.”
“It’s a snapshot of all the symptoms that can remain after COVID-19,” Dr. Lopez-Leon explained. “The meta-analysis seeks to see if there’s an association between having had COVID-19 and having the symptoms, but at no time does it speak of causality.”
The prevalence of symptoms largely depends on the time since the onset of acute COVID-19. Most symptoms improve over time. In the studies that were included in the meta-analysis, the follow-up time varied between 1 and 13 months. It is important to understand what symptoms are associated with each period after the onset of infection, the authors said.
Danish parent survey
The Danish study LongCOVIDKidsDK followed the World Health Organization criteria for long COVID-19 and included children and adolescents aged 0-14 years who received a diagnosis of COVID-19 and who experienced symptoms that lasted at least 2 months.
Between July 20, 2021, and Sept. 15, 2021, a questionnaire was sent to 38,152 case patients and 147,212 control persons. Of this group, 10,997 (28.8%) case patients and 33,016 (22.4%) control persons answered the survey.
Children who had been diagnosed with SARS-CoV-2 infection were more likely to experience long-lasting symptoms than children who had never been diagnosed. Approximately one-third of children with a positive SARS-CoV-2 test experienced symptoms that were not present before infection. Children who experienced long-lasting symptoms included 40% of children diagnosed with COVID-19 and 27% of control persons aged 0-3 years, 38% of case patients and 34% of control persons aged 4-11 years, and 46% of case patients and 41% of control persons aged 12-14 years.
Interestingly, those diagnosed with COVID-19 reported fewer psychological and social problems than those in the control group. Among the oldest (aged 12-14 years), quality of life scores were higher and anxiety scores were lower for those who had tested positive for SARS-CoV-2.
More information needed
Given the diversity of symptoms in the meta-analysis and the LongCOVIDKidsDK study, a multidisciplinary approach is imperative. Dr. Lopez-Leon suggests that there is a need to raise awareness among parents, clinicians, researchers, and the health system about the conditions that can occur after COVID-19. Clinicians must better understand the sequelae to provide targeted care and treatment. The authors of the Danish study recommend establishing clinics for long COVID-19 with multispecialty care.
Maren J. Heilskov Rytter, PhD, associate professor of clinical medicine at the University of Copenhagen, wrote an editorial in The Lancet Child and Adolescent Health about the Danish study. Until it is clarified whether SARS-CoV-2 does indeed cause persistent symptoms, she wrote, “it seems excessive and premature to establish specific multidisciplinary clinics for children with long COVID-19.”
Dr. Rytter highlighted the difficulty of interpreting LongCOVIDKidsDK data, owing to recall bias, the failure to exclude other causes of symptoms in the cases analyzed, and the number of symptoms in the control persons. In addition, the data analyzed in Denmark are of limited clinical relevance, she said, given a greater presence of mild symptoms and, paradoxically, a higher quality of life.
She concluded, “In the majority of children with nonspecific symptoms after COVID-19, the symptoms presented are more likely to have been caused by something other than COVID-19, and if they are related to COVID-19, they are likely to go away over time.”
Dr. Ensinck, who is coauthor of the Argentine Ministry of Health’s guide for long COVID-19 monitoring for children and adolescents and who represented the Infectious Diseases Committee of the Argentine Society of Pediatrics, highlighted another aspect of the problem. “What should be taken into account in these data is to see how much the confinement contributed. Children are the ones who suffered the most in the period in which schools were closed; they could not meet their peers, they had sick relatives, they felt fear. … all this must be taken into account.”
There is as yet no agreement on how to define and diagnose long COVID-19 in adults, a population that has been studied more closely. Part of the problem is that long COVID-19 has been linked to more than 200 symptoms, which can range in severity from inconvenient to debilitating, can last for months or years, and can recur, sometimes months after apparent recovery. Thus, there are still disparate answers to basic questions about the syndrome’s frequency and its effects on vaccination, reinfection, and the latest variant of SARS-CoV-2.
This article has been translated from the Medscape Spanish edition. A version appeared on Medscape.com.
FROM SCIENTIFIC REPORTS AND THE LANCET CHILD AND ADOLESCENT HEALTH
Roe v. Wade overturned: A family medicine resident reacts
I remember how small and shy she looked, curled into herself in her too-large hospital gown. I remember thinking that it was autumn, and she should have been at her first homecoming dance, not sitting in the ER staring mutely at the hospital-issued safety socks on her feet. Her mother, puffy-eyed from crying, was sitting on the bed beside her, stroking her hair.
Together, my patients and I talked about the pregnancy. She told me how scared she was, how she didn’t want to “kill her baby”, but that she also wasn’t sure she could take care of a child. She told me that she was terrified of childbirth, that she didn’t want her friends at school to know and to judge her. We talked about how she was a victim; how she was an innocent child, too. I reassured her, and her mom emphatically agreed – her body was still her own.
The man who hurt her did not take that from her. She could make any choice she wanted, and it would be the right choice.
Eventually, she was able to make a decision which was best for her. I don’t know what became of her, but I hope she is well now, and I hope she’s thriving and happy. I also hope that she doesn’t see the news about Roe v. Wade and feel stripped of her personhood, as many women did.
When I heard about the Supreme Court decision I thought of her, and how important our conversation was to the trajectory of her life. I wondered if across the country these conversations might be silenced, and patients might be left to navigate this important facet of their health alone.
Some version of the conversation I had with my young patient occurs in exam rooms across the country countless times a day. Sometimes these conversations are cut and dry. Other times, they are accompanied by heartbreak and tears.
These conversations are common – one in four women in the United States have had an abortion. I have had many friends who were faced with deciding what to do after an unexpectedly positive pregnancy test. The reasons were different for each person – one was raped at a party, another’s birth control failed, the boyfriend of a third friend wouldn’t wear a condom – but the underlying sentiments were the same for each woman. They thought: “This is a difficult choice, but it’s a choice I’m ready to make. I’m not ready to have a baby at this point in my life.”
My friends talked to their doctors, who assisted them in making an informed choice. Some of them chose abortion. Others chose to deliver their baby. All were helped along in their decision by a physician who was there to support them and assist them in making a well-considered choice for their individual circumstance.
Economic and health consequences of restricting access to abortion
The facts are clear: Nearly half of all pregnancies in American women in 2011 were unplanned, and about 4 in 10 of them ended in an elective abortion, according to the Guttmacher Institute.1 Restricting access to abortions does not stop abortions from happening; it limits the opportunity for women to seek advice from trusted friends and professionals and it reduces access to safe abortions.
The people who will be most harmed by these restrictions are the most socially and economically vulnerable. Wealthy, mobile women with the ability to travel to other states or countries will always be able to access abortion care; low-income, work-tethered women and women with other children to care for at home will struggle to do so.
Denying women abortion services puts them at increased risk for lifelong, multigenerational economic hardship. Women who sought abortions but were unable to obtain them experienced an increase in household poverty which lasted years relative to women who were able to receive an abortion, according to the authors of The Turnaway Study.2 They were less socially, geographically, and economically mobile, and were less likely to go on to receive a higher education.
In a country where citizens do not have paid maternity leave, affordable and accessible childcare services, or universal health care, raising a child is an enormous financial burden. Women who are denied abortions also are much more likely to end up as a single parent, shouldering that burden alone.
Additionally, low socioeconomic status is associated with increased all-cause mortality. People who live in poverty are disproportionately affected by diabetes and other chronic health conditions, and have lower life expectancies overall.
The reversal of Roe v. Wade is not only going to lead directly to patient death by decreasing access to safe abortion, causing women to pursue unsafe alternatives; it will also indirectly result in more women being driven into and remaining in poverty and suffering the health consequences.
In addition to risking a woman’s life medically, pregnancy also significantly increases that individual’s risk of being a victim of intimate partner violence. The number one cause of death in pregnant women is homicide, most often by their sexual partner, said an article published in Nature in 2021.3 Therefore, restricting a woman’s ability to control if and when she has children could put her at risk for death from serious pregnancy-related complications and unsafe abortion consequences and increase her likelihood of dying by domestic violence.
Patient-physicians interactions are changed
As a physician I hope that I am able to convey my intense respect for and support of a woman’s autonomy into every family planning visit I conduct. Unfortunately, this ruling will not only have an immediate impact on the lives of women across the country – it will also alter the way many of us interact with our patients on a day-to-day basis. When patients can report doctors to authorities in some states for offering terminations, and doctors can report patients for seeking them, there will be absolutely no trust in the therapeutic relationship.
With this ruling, the content of private and protected conversations between patients and their physicians will be subject to censure and potentially criminal consequences.
Regardless of where I eventually practice medicine, I should not be in the position of talking to a patient and telling them that they do not have any agency over their body unless they have the money and resources to travel to a state where abortion is legal. I should not have to tell a child that she must carry and birth another child just to appease the often-fickle whims of lawmakers.
The conversation I had with my pediatric patient was important to her health and to her future, and she deserved to have the chance to discuss her feelings with a trusted physician. Every woman has the right to make her own decisions within the sanctity of the exam room, not from the distance of a courtroom.
Dr. Persampiere is a resident in the family medicine residency program at Abington (Pa.) Jefferson Health. You can contact her directly at [email protected] or via [email protected].
References
1. Unintended pregnancy in the United States. Guttmacher Institute. 2019 Jan 9. https://www.guttmacher.org/fact-sheet/unintended-pregnancy-united-states
2. Foster D et al. The harms of denying a woman a wanted abortion - ANSIRH. https://www.ansirh.org/sites/default/files/publications/files/the_harms_of_denying_a_woman_a_wanted_abortion_4-16-2020.pdf
3. Subbaraman N. 2021 Nov 12. Homicide is a top cause of maternal death in the United States. Nature News. https://www.nature.com/articles/d41586-021-03392-8
I remember how small and shy she looked, curled into herself in her too-large hospital gown. I remember thinking that it was autumn, and she should have been at her first homecoming dance, not sitting in the ER staring mutely at the hospital-issued safety socks on her feet. Her mother, puffy-eyed from crying, was sitting on the bed beside her, stroking her hair.
Together, my patients and I talked about the pregnancy. She told me how scared she was, how she didn’t want to “kill her baby”, but that she also wasn’t sure she could take care of a child. She told me that she was terrified of childbirth, that she didn’t want her friends at school to know and to judge her. We talked about how she was a victim; how she was an innocent child, too. I reassured her, and her mom emphatically agreed – her body was still her own.
The man who hurt her did not take that from her. She could make any choice she wanted, and it would be the right choice.
Eventually, she was able to make a decision which was best for her. I don’t know what became of her, but I hope she is well now, and I hope she’s thriving and happy. I also hope that she doesn’t see the news about Roe v. Wade and feel stripped of her personhood, as many women did.
When I heard about the Supreme Court decision I thought of her, and how important our conversation was to the trajectory of her life. I wondered if across the country these conversations might be silenced, and patients might be left to navigate this important facet of their health alone.
Some version of the conversation I had with my young patient occurs in exam rooms across the country countless times a day. Sometimes these conversations are cut and dry. Other times, they are accompanied by heartbreak and tears.
These conversations are common – one in four women in the United States have had an abortion. I have had many friends who were faced with deciding what to do after an unexpectedly positive pregnancy test. The reasons were different for each person – one was raped at a party, another’s birth control failed, the boyfriend of a third friend wouldn’t wear a condom – but the underlying sentiments were the same for each woman. They thought: “This is a difficult choice, but it’s a choice I’m ready to make. I’m not ready to have a baby at this point in my life.”
My friends talked to their doctors, who assisted them in making an informed choice. Some of them chose abortion. Others chose to deliver their baby. All were helped along in their decision by a physician who was there to support them and assist them in making a well-considered choice for their individual circumstance.
Economic and health consequences of restricting access to abortion
The facts are clear: Nearly half of all pregnancies in American women in 2011 were unplanned, and about 4 in 10 of them ended in an elective abortion, according to the Guttmacher Institute.1 Restricting access to abortions does not stop abortions from happening; it limits the opportunity for women to seek advice from trusted friends and professionals and it reduces access to safe abortions.
The people who will be most harmed by these restrictions are the most socially and economically vulnerable. Wealthy, mobile women with the ability to travel to other states or countries will always be able to access abortion care; low-income, work-tethered women and women with other children to care for at home will struggle to do so.
Denying women abortion services puts them at increased risk for lifelong, multigenerational economic hardship. Women who sought abortions but were unable to obtain them experienced an increase in household poverty which lasted years relative to women who were able to receive an abortion, according to the authors of The Turnaway Study.2 They were less socially, geographically, and economically mobile, and were less likely to go on to receive a higher education.
In a country where citizens do not have paid maternity leave, affordable and accessible childcare services, or universal health care, raising a child is an enormous financial burden. Women who are denied abortions also are much more likely to end up as a single parent, shouldering that burden alone.
Additionally, low socioeconomic status is associated with increased all-cause mortality. People who live in poverty are disproportionately affected by diabetes and other chronic health conditions, and have lower life expectancies overall.
The reversal of Roe v. Wade is not only going to lead directly to patient death by decreasing access to safe abortion, causing women to pursue unsafe alternatives; it will also indirectly result in more women being driven into and remaining in poverty and suffering the health consequences.
In addition to risking a woman’s life medically, pregnancy also significantly increases that individual’s risk of being a victim of intimate partner violence. The number one cause of death in pregnant women is homicide, most often by their sexual partner, said an article published in Nature in 2021.3 Therefore, restricting a woman’s ability to control if and when she has children could put her at risk for death from serious pregnancy-related complications and unsafe abortion consequences and increase her likelihood of dying by domestic violence.
Patient-physicians interactions are changed
As a physician I hope that I am able to convey my intense respect for and support of a woman’s autonomy into every family planning visit I conduct. Unfortunately, this ruling will not only have an immediate impact on the lives of women across the country – it will also alter the way many of us interact with our patients on a day-to-day basis. When patients can report doctors to authorities in some states for offering terminations, and doctors can report patients for seeking them, there will be absolutely no trust in the therapeutic relationship.
With this ruling, the content of private and protected conversations between patients and their physicians will be subject to censure and potentially criminal consequences.
Regardless of where I eventually practice medicine, I should not be in the position of talking to a patient and telling them that they do not have any agency over their body unless they have the money and resources to travel to a state where abortion is legal. I should not have to tell a child that she must carry and birth another child just to appease the often-fickle whims of lawmakers.
The conversation I had with my pediatric patient was important to her health and to her future, and she deserved to have the chance to discuss her feelings with a trusted physician. Every woman has the right to make her own decisions within the sanctity of the exam room, not from the distance of a courtroom.
Dr. Persampiere is a resident in the family medicine residency program at Abington (Pa.) Jefferson Health. You can contact her directly at [email protected] or via [email protected].
References
1. Unintended pregnancy in the United States. Guttmacher Institute. 2019 Jan 9. https://www.guttmacher.org/fact-sheet/unintended-pregnancy-united-states
2. Foster D et al. The harms of denying a woman a wanted abortion - ANSIRH. https://www.ansirh.org/sites/default/files/publications/files/the_harms_of_denying_a_woman_a_wanted_abortion_4-16-2020.pdf
3. Subbaraman N. 2021 Nov 12. Homicide is a top cause of maternal death in the United States. Nature News. https://www.nature.com/articles/d41586-021-03392-8
I remember how small and shy she looked, curled into herself in her too-large hospital gown. I remember thinking that it was autumn, and she should have been at her first homecoming dance, not sitting in the ER staring mutely at the hospital-issued safety socks on her feet. Her mother, puffy-eyed from crying, was sitting on the bed beside her, stroking her hair.
Together, my patients and I talked about the pregnancy. She told me how scared she was, how she didn’t want to “kill her baby”, but that she also wasn’t sure she could take care of a child. She told me that she was terrified of childbirth, that she didn’t want her friends at school to know and to judge her. We talked about how she was a victim; how she was an innocent child, too. I reassured her, and her mom emphatically agreed – her body was still her own.
The man who hurt her did not take that from her. She could make any choice she wanted, and it would be the right choice.
Eventually, she was able to make a decision which was best for her. I don’t know what became of her, but I hope she is well now, and I hope she’s thriving and happy. I also hope that she doesn’t see the news about Roe v. Wade and feel stripped of her personhood, as many women did.
When I heard about the Supreme Court decision I thought of her, and how important our conversation was to the trajectory of her life. I wondered if across the country these conversations might be silenced, and patients might be left to navigate this important facet of their health alone.
Some version of the conversation I had with my young patient occurs in exam rooms across the country countless times a day. Sometimes these conversations are cut and dry. Other times, they are accompanied by heartbreak and tears.
These conversations are common – one in four women in the United States have had an abortion. I have had many friends who were faced with deciding what to do after an unexpectedly positive pregnancy test. The reasons were different for each person – one was raped at a party, another’s birth control failed, the boyfriend of a third friend wouldn’t wear a condom – but the underlying sentiments were the same for each woman. They thought: “This is a difficult choice, but it’s a choice I’m ready to make. I’m not ready to have a baby at this point in my life.”
My friends talked to their doctors, who assisted them in making an informed choice. Some of them chose abortion. Others chose to deliver their baby. All were helped along in their decision by a physician who was there to support them and assist them in making a well-considered choice for their individual circumstance.
Economic and health consequences of restricting access to abortion
The facts are clear: Nearly half of all pregnancies in American women in 2011 were unplanned, and about 4 in 10 of them ended in an elective abortion, according to the Guttmacher Institute.1 Restricting access to abortions does not stop abortions from happening; it limits the opportunity for women to seek advice from trusted friends and professionals and it reduces access to safe abortions.
The people who will be most harmed by these restrictions are the most socially and economically vulnerable. Wealthy, mobile women with the ability to travel to other states or countries will always be able to access abortion care; low-income, work-tethered women and women with other children to care for at home will struggle to do so.
Denying women abortion services puts them at increased risk for lifelong, multigenerational economic hardship. Women who sought abortions but were unable to obtain them experienced an increase in household poverty which lasted years relative to women who were able to receive an abortion, according to the authors of The Turnaway Study.2 They were less socially, geographically, and economically mobile, and were less likely to go on to receive a higher education.
In a country where citizens do not have paid maternity leave, affordable and accessible childcare services, or universal health care, raising a child is an enormous financial burden. Women who are denied abortions also are much more likely to end up as a single parent, shouldering that burden alone.
Additionally, low socioeconomic status is associated with increased all-cause mortality. People who live in poverty are disproportionately affected by diabetes and other chronic health conditions, and have lower life expectancies overall.
The reversal of Roe v. Wade is not only going to lead directly to patient death by decreasing access to safe abortion, causing women to pursue unsafe alternatives; it will also indirectly result in more women being driven into and remaining in poverty and suffering the health consequences.
In addition to risking a woman’s life medically, pregnancy also significantly increases that individual’s risk of being a victim of intimate partner violence. The number one cause of death in pregnant women is homicide, most often by their sexual partner, said an article published in Nature in 2021.3 Therefore, restricting a woman’s ability to control if and when she has children could put her at risk for death from serious pregnancy-related complications and unsafe abortion consequences and increase her likelihood of dying by domestic violence.
Patient-physicians interactions are changed
As a physician I hope that I am able to convey my intense respect for and support of a woman’s autonomy into every family planning visit I conduct. Unfortunately, this ruling will not only have an immediate impact on the lives of women across the country – it will also alter the way many of us interact with our patients on a day-to-day basis. When patients can report doctors to authorities in some states for offering terminations, and doctors can report patients for seeking them, there will be absolutely no trust in the therapeutic relationship.
With this ruling, the content of private and protected conversations between patients and their physicians will be subject to censure and potentially criminal consequences.
Regardless of where I eventually practice medicine, I should not be in the position of talking to a patient and telling them that they do not have any agency over their body unless they have the money and resources to travel to a state where abortion is legal. I should not have to tell a child that she must carry and birth another child just to appease the often-fickle whims of lawmakers.
The conversation I had with my pediatric patient was important to her health and to her future, and she deserved to have the chance to discuss her feelings with a trusted physician. Every woman has the right to make her own decisions within the sanctity of the exam room, not from the distance of a courtroom.
Dr. Persampiere is a resident in the family medicine residency program at Abington (Pa.) Jefferson Health. You can contact her directly at [email protected] or via [email protected].
References
1. Unintended pregnancy in the United States. Guttmacher Institute. 2019 Jan 9. https://www.guttmacher.org/fact-sheet/unintended-pregnancy-united-states
2. Foster D et al. The harms of denying a woman a wanted abortion - ANSIRH. https://www.ansirh.org/sites/default/files/publications/files/the_harms_of_denying_a_woman_a_wanted_abortion_4-16-2020.pdf
3. Subbaraman N. 2021 Nov 12. Homicide is a top cause of maternal death in the United States. Nature News. https://www.nature.com/articles/d41586-021-03392-8
Select patients with breast cancer may skip RT after lumpectomy
The women in this trial who skipped radiotherapy, and were treated with breast-conserving surgery followed by endocrine therapy, had an overall survival rate of 97.2%. The local recurrence rate was 2.3%, which was the study’s primary endpoint.
“Women 55 and over, with low-grade luminal A-type breast cancer, following breast conserving surgery and treated with endocrine therapy alone, had a very low rate of local recurrence at 5 years,” commented lead author Timothy Joseph Whelan, MD.
“The prospective and multicenter nature of this study supports that these patients are candidates for the omission of radiotherapy,” said Dr. Whelan, oncology professor and Canada Research Chair in Breast Cancer Research at McMaster University and a radiation oncologist at the Juravinski Cancer Centre, both in Hamilton, Ont.
“Over 300,000 [people] are diagnosed with invasive breast cancer in North America annually, the majority in the United States,” said Dr. Whelan. “We estimate that these results could apply to 10%-15% of them, so about 30,000-40,000 women per year who could avoid the morbidity, the cost, and inconvenience of radiotherapy.”
The results were presented at the annual meeting of the American Society of Clinical Oncology.
Dr. Whelan explained that adjuvant radiation therapy is generally prescribed following breast conservation therapy to lower the risk of local recurrence, but the treatment is also associated with acute and late toxicity. In addition, it can incur high costs and inconvenience for the patient.
Previous studies have found that among women older than 60 with low-grade, luminal A-type breast cancer who received only breast-conserving surgery, there was a low rate of local recurrence. In women aged older than 70 years, the risk of local recurrence was about 4%-5%.
This latest study focused on patients with breast cancer with a luminal A subtype combined with clinical pathological factors (defined as estrogen receptor ≥ 1%, progesterone receptor > 20%, HER2 negative, and Ki67 ≤ 13.25%).
This was a prospective, multicenter cohort study that included 501 patients aged 55 years and older who had undergone breast-conserving surgery for grade 1-2 T1N0 cancer.
The median patient age was 67, with 442 (88%) older than 75 years. The median tumor size was 1.1 cm.
Median follow-up was 5 years. The cohort was followed every 6 months for the first 2 years and then annually.
The primary outcome was local recurrence defined as time from enrollment to any invasive or noninvasive cancer in the ipsilateral breast, and secondary endpoints included contralateral breast cancer, relapse-free survival based on any recurrence, disease free survival, second cancer or death, and overall survival.
At five years, there were 10 events of local recurrence, for a rate of 2.3%. For secondary outcomes, there were eight events of contralateral breast cancer (1.9%); 12 relapses for a recurrence-free survival rate of 97.3%; 47 disease progression (23 second nonbreast cancers) for a disease-free survival rate of 89.9%; and 13 deaths, including 1 from breast cancer, for an overall survival of 97.2%.
Confirms earlier data
Penny R. Anderson, MD, professor in the department of radiation oncology at Fox Chase Cancer Center, Philadelphia, commented that this was an “extremely well-designed and important study.
“It has identified a specific subset of patients to be appropriate candidates for consideration of omission of adjuvant breast radiation therapy after breast-conserving surgery,” she added.
Although previously published trials have helped identify certain patient groups who have a low risk of local recurrence – and therefore, for whom it may be appropriate to omit radiation – they have been based on the traditional clinical and pathologic factors of tumor size, margin status, receptor status, and patient age.
“This LUMINA trial utilizes the molecular-defined intrinsic subtype of luminal A breast cancer to provide additional prognostic information,” she said. “This finding certainly suggests that this group of patients are ideal candidates for the omission of radiation, and that this should be discussed with these patients as a potential option in their treatment management.”
Overall, this trial is a “significant addition and a very relevant contribution to the literature demonstrating that adjuvant breast radiation may safely be omitted in this particular subgroup of breast cancer patients,” she said.
Unanswered questions
Commenting on the study, Julie Gralow, MD, chief medical officer and executive vice president of ASCO, told this news organization that she thinks the take-home message is that there is “clearly a population of early-stage breast cancer [patients] who after lumpectomy do not benefit from radiation.”
“I think where there will be discussion will be what is the optimal way of identifying that group,” she said, noting that in this study the patients were screened for Ki67, a marker of proliferation.
Testing for Ki67 is not the standard of care, Dr. Gralow pointed out, and there is also a problem with reproducibility since “every lab does it somewhat differently, because it is not a standard pathology approach.”
There are now many unanswered questions, she noted. “Do we need that central testing of Ki67? Do we need to develop guidelines for how to do this? Is this better than if you’ve already run an Oncotype or a MammaPrint test to see if the patient needs chemo, then would that suffice? That is where the discussion will be. We can reduce the number of patients who need radiation without an increase in local regional recurrence.”
In terms of clinical practice, Dr. Gralow explained that there are already some data supporting the omission of radiation therapy in an older population with ER-positive small low-grade tumors, and this has become a standard clinical practice. “It’s not based on solid data, but based on an accumulation of retrospective analyses,” she said. “So we have already been doing it for an older population. This would bring down the age group, and it would better define it, and test it prospectively.”
Limitations to note
Also commenting on the study, Deborah Axelrod, MD, director of clinical breast surgery at New York University Langone’s Perlmutter Cancer Center, explained that, in the last decade, knowledge about the behavior of breast cancers based on molecular subtyping has greatly increased. “Results of studies such as this have given us information on which cancers need more treatment and for which cancers we can de-escalate treatment,” she said. “Refining this more, it’s about reducing the morbidity and improving quality of life without compromising the oncological outcome.”
She noted that a big strength of this LUMINA study is that it is prospective and multicenter. “It has been supported by other past studies as well and will define for which patients with newly treated breast cancers can we omit radiation, which has been the standard of care,” said Dr. Axelrod. “It is based on the age and biology of breast cancer in defining which patient can forgo radiation and showed a low risk of recurrence in a specific population of women with a favorable breast cancer profile”
There were limitations to the study. “There is a 5-year follow-up and local recurrence for ER-positive cancers continues to rise after 5 years, so longer-term follow-up will be important,” she said. Also, she pointed out that it is a single-arm study so there is no radiation therapy comparison arm.
Other limitations were that the patients were older with smaller tumors, and all were committed to 5 years of endocrine therapy, although compliance with that has not been reported. There may be some older patients who prefer radiation therapy, especially a week of accelerated partial breast irradiation, rather than commit to 5 years of endocrine therapy as mandated in this study.
“Overall, the takeaway message for patients is that the omission of radiation therapy should be considered an option for older women with localized breast cancer with favorable features who receive endocrine therapies,” said Dr. Axelrod.
LUMINA was sponsored by the Canadian Breast Cancer Foundation and the Canadian Cancer Society. Dr. Whelan has reported research funding from Exact Sciences (Inst). Dr. Axelrod and Dr. Anderson reported no disclosures. Dr. Gralow reported relationships with Genentech, AstraZeneca, Hexal, Puma BioTechnology, Roche, Novartis, Seagen, and Genomic Health.
A version of this article first appeared on Medscape.com.
The women in this trial who skipped radiotherapy, and were treated with breast-conserving surgery followed by endocrine therapy, had an overall survival rate of 97.2%. The local recurrence rate was 2.3%, which was the study’s primary endpoint.
“Women 55 and over, with low-grade luminal A-type breast cancer, following breast conserving surgery and treated with endocrine therapy alone, had a very low rate of local recurrence at 5 years,” commented lead author Timothy Joseph Whelan, MD.
“The prospective and multicenter nature of this study supports that these patients are candidates for the omission of radiotherapy,” said Dr. Whelan, oncology professor and Canada Research Chair in Breast Cancer Research at McMaster University and a radiation oncologist at the Juravinski Cancer Centre, both in Hamilton, Ont.
“Over 300,000 [people] are diagnosed with invasive breast cancer in North America annually, the majority in the United States,” said Dr. Whelan. “We estimate that these results could apply to 10%-15% of them, so about 30,000-40,000 women per year who could avoid the morbidity, the cost, and inconvenience of radiotherapy.”
The results were presented at the annual meeting of the American Society of Clinical Oncology.
Dr. Whelan explained that adjuvant radiation therapy is generally prescribed following breast conservation therapy to lower the risk of local recurrence, but the treatment is also associated with acute and late toxicity. In addition, it can incur high costs and inconvenience for the patient.
Previous studies have found that among women older than 60 with low-grade, luminal A-type breast cancer who received only breast-conserving surgery, there was a low rate of local recurrence. In women aged older than 70 years, the risk of local recurrence was about 4%-5%.
This latest study focused on patients with breast cancer with a luminal A subtype combined with clinical pathological factors (defined as estrogen receptor ≥ 1%, progesterone receptor > 20%, HER2 negative, and Ki67 ≤ 13.25%).
This was a prospective, multicenter cohort study that included 501 patients aged 55 years and older who had undergone breast-conserving surgery for grade 1-2 T1N0 cancer.
The median patient age was 67, with 442 (88%) older than 75 years. The median tumor size was 1.1 cm.
Median follow-up was 5 years. The cohort was followed every 6 months for the first 2 years and then annually.
The primary outcome was local recurrence defined as time from enrollment to any invasive or noninvasive cancer in the ipsilateral breast, and secondary endpoints included contralateral breast cancer, relapse-free survival based on any recurrence, disease free survival, second cancer or death, and overall survival.
At five years, there were 10 events of local recurrence, for a rate of 2.3%. For secondary outcomes, there were eight events of contralateral breast cancer (1.9%); 12 relapses for a recurrence-free survival rate of 97.3%; 47 disease progression (23 second nonbreast cancers) for a disease-free survival rate of 89.9%; and 13 deaths, including 1 from breast cancer, for an overall survival of 97.2%.
Confirms earlier data
Penny R. Anderson, MD, professor in the department of radiation oncology at Fox Chase Cancer Center, Philadelphia, commented that this was an “extremely well-designed and important study.
“It has identified a specific subset of patients to be appropriate candidates for consideration of omission of adjuvant breast radiation therapy after breast-conserving surgery,” she added.
Although previously published trials have helped identify certain patient groups who have a low risk of local recurrence – and therefore, for whom it may be appropriate to omit radiation – they have been based on the traditional clinical and pathologic factors of tumor size, margin status, receptor status, and patient age.
“This LUMINA trial utilizes the molecular-defined intrinsic subtype of luminal A breast cancer to provide additional prognostic information,” she said. “This finding certainly suggests that this group of patients are ideal candidates for the omission of radiation, and that this should be discussed with these patients as a potential option in their treatment management.”
Overall, this trial is a “significant addition and a very relevant contribution to the literature demonstrating that adjuvant breast radiation may safely be omitted in this particular subgroup of breast cancer patients,” she said.
Unanswered questions
Commenting on the study, Julie Gralow, MD, chief medical officer and executive vice president of ASCO, told this news organization that she thinks the take-home message is that there is “clearly a population of early-stage breast cancer [patients] who after lumpectomy do not benefit from radiation.”
“I think where there will be discussion will be what is the optimal way of identifying that group,” she said, noting that in this study the patients were screened for Ki67, a marker of proliferation.
Testing for Ki67 is not the standard of care, Dr. Gralow pointed out, and there is also a problem with reproducibility since “every lab does it somewhat differently, because it is not a standard pathology approach.”
There are now many unanswered questions, she noted. “Do we need that central testing of Ki67? Do we need to develop guidelines for how to do this? Is this better than if you’ve already run an Oncotype or a MammaPrint test to see if the patient needs chemo, then would that suffice? That is where the discussion will be. We can reduce the number of patients who need radiation without an increase in local regional recurrence.”
In terms of clinical practice, Dr. Gralow explained that there are already some data supporting the omission of radiation therapy in an older population with ER-positive small low-grade tumors, and this has become a standard clinical practice. “It’s not based on solid data, but based on an accumulation of retrospective analyses,” she said. “So we have already been doing it for an older population. This would bring down the age group, and it would better define it, and test it prospectively.”
Limitations to note
Also commenting on the study, Deborah Axelrod, MD, director of clinical breast surgery at New York University Langone’s Perlmutter Cancer Center, explained that, in the last decade, knowledge about the behavior of breast cancers based on molecular subtyping has greatly increased. “Results of studies such as this have given us information on which cancers need more treatment and for which cancers we can de-escalate treatment,” she said. “Refining this more, it’s about reducing the morbidity and improving quality of life without compromising the oncological outcome.”
She noted that a big strength of this LUMINA study is that it is prospective and multicenter. “It has been supported by other past studies as well and will define for which patients with newly treated breast cancers can we omit radiation, which has been the standard of care,” said Dr. Axelrod. “It is based on the age and biology of breast cancer in defining which patient can forgo radiation and showed a low risk of recurrence in a specific population of women with a favorable breast cancer profile”
There were limitations to the study. “There is a 5-year follow-up and local recurrence for ER-positive cancers continues to rise after 5 years, so longer-term follow-up will be important,” she said. Also, she pointed out that it is a single-arm study so there is no radiation therapy comparison arm.
Other limitations were that the patients were older with smaller tumors, and all were committed to 5 years of endocrine therapy, although compliance with that has not been reported. There may be some older patients who prefer radiation therapy, especially a week of accelerated partial breast irradiation, rather than commit to 5 years of endocrine therapy as mandated in this study.
“Overall, the takeaway message for patients is that the omission of radiation therapy should be considered an option for older women with localized breast cancer with favorable features who receive endocrine therapies,” said Dr. Axelrod.
LUMINA was sponsored by the Canadian Breast Cancer Foundation and the Canadian Cancer Society. Dr. Whelan has reported research funding from Exact Sciences (Inst). Dr. Axelrod and Dr. Anderson reported no disclosures. Dr. Gralow reported relationships with Genentech, AstraZeneca, Hexal, Puma BioTechnology, Roche, Novartis, Seagen, and Genomic Health.
A version of this article first appeared on Medscape.com.
The women in this trial who skipped radiotherapy, and were treated with breast-conserving surgery followed by endocrine therapy, had an overall survival rate of 97.2%. The local recurrence rate was 2.3%, which was the study’s primary endpoint.
“Women 55 and over, with low-grade luminal A-type breast cancer, following breast conserving surgery and treated with endocrine therapy alone, had a very low rate of local recurrence at 5 years,” commented lead author Timothy Joseph Whelan, MD.
“The prospective and multicenter nature of this study supports that these patients are candidates for the omission of radiotherapy,” said Dr. Whelan, oncology professor and Canada Research Chair in Breast Cancer Research at McMaster University and a radiation oncologist at the Juravinski Cancer Centre, both in Hamilton, Ont.
“Over 300,000 [people] are diagnosed with invasive breast cancer in North America annually, the majority in the United States,” said Dr. Whelan. “We estimate that these results could apply to 10%-15% of them, so about 30,000-40,000 women per year who could avoid the morbidity, the cost, and inconvenience of radiotherapy.”
The results were presented at the annual meeting of the American Society of Clinical Oncology.
Dr. Whelan explained that adjuvant radiation therapy is generally prescribed following breast conservation therapy to lower the risk of local recurrence, but the treatment is also associated with acute and late toxicity. In addition, it can incur high costs and inconvenience for the patient.
Previous studies have found that among women older than 60 with low-grade, luminal A-type breast cancer who received only breast-conserving surgery, there was a low rate of local recurrence. In women aged older than 70 years, the risk of local recurrence was about 4%-5%.
This latest study focused on patients with breast cancer with a luminal A subtype combined with clinical pathological factors (defined as estrogen receptor ≥ 1%, progesterone receptor > 20%, HER2 negative, and Ki67 ≤ 13.25%).
This was a prospective, multicenter cohort study that included 501 patients aged 55 years and older who had undergone breast-conserving surgery for grade 1-2 T1N0 cancer.
The median patient age was 67, with 442 (88%) older than 75 years. The median tumor size was 1.1 cm.
Median follow-up was 5 years. The cohort was followed every 6 months for the first 2 years and then annually.
The primary outcome was local recurrence defined as time from enrollment to any invasive or noninvasive cancer in the ipsilateral breast, and secondary endpoints included contralateral breast cancer, relapse-free survival based on any recurrence, disease free survival, second cancer or death, and overall survival.
At five years, there were 10 events of local recurrence, for a rate of 2.3%. For secondary outcomes, there were eight events of contralateral breast cancer (1.9%); 12 relapses for a recurrence-free survival rate of 97.3%; 47 disease progression (23 second nonbreast cancers) for a disease-free survival rate of 89.9%; and 13 deaths, including 1 from breast cancer, for an overall survival of 97.2%.
Confirms earlier data
Penny R. Anderson, MD, professor in the department of radiation oncology at Fox Chase Cancer Center, Philadelphia, commented that this was an “extremely well-designed and important study.
“It has identified a specific subset of patients to be appropriate candidates for consideration of omission of adjuvant breast radiation therapy after breast-conserving surgery,” she added.
Although previously published trials have helped identify certain patient groups who have a low risk of local recurrence – and therefore, for whom it may be appropriate to omit radiation – they have been based on the traditional clinical and pathologic factors of tumor size, margin status, receptor status, and patient age.
“This LUMINA trial utilizes the molecular-defined intrinsic subtype of luminal A breast cancer to provide additional prognostic information,” she said. “This finding certainly suggests that this group of patients are ideal candidates for the omission of radiation, and that this should be discussed with these patients as a potential option in their treatment management.”
Overall, this trial is a “significant addition and a very relevant contribution to the literature demonstrating that adjuvant breast radiation may safely be omitted in this particular subgroup of breast cancer patients,” she said.
Unanswered questions
Commenting on the study, Julie Gralow, MD, chief medical officer and executive vice president of ASCO, told this news organization that she thinks the take-home message is that there is “clearly a population of early-stage breast cancer [patients] who after lumpectomy do not benefit from radiation.”
“I think where there will be discussion will be what is the optimal way of identifying that group,” she said, noting that in this study the patients were screened for Ki67, a marker of proliferation.
Testing for Ki67 is not the standard of care, Dr. Gralow pointed out, and there is also a problem with reproducibility since “every lab does it somewhat differently, because it is not a standard pathology approach.”
There are now many unanswered questions, she noted. “Do we need that central testing of Ki67? Do we need to develop guidelines for how to do this? Is this better than if you’ve already run an Oncotype or a MammaPrint test to see if the patient needs chemo, then would that suffice? That is where the discussion will be. We can reduce the number of patients who need radiation without an increase in local regional recurrence.”
In terms of clinical practice, Dr. Gralow explained that there are already some data supporting the omission of radiation therapy in an older population with ER-positive small low-grade tumors, and this has become a standard clinical practice. “It’s not based on solid data, but based on an accumulation of retrospective analyses,” she said. “So we have already been doing it for an older population. This would bring down the age group, and it would better define it, and test it prospectively.”
Limitations to note
Also commenting on the study, Deborah Axelrod, MD, director of clinical breast surgery at New York University Langone’s Perlmutter Cancer Center, explained that, in the last decade, knowledge about the behavior of breast cancers based on molecular subtyping has greatly increased. “Results of studies such as this have given us information on which cancers need more treatment and for which cancers we can de-escalate treatment,” she said. “Refining this more, it’s about reducing the morbidity and improving quality of life without compromising the oncological outcome.”
She noted that a big strength of this LUMINA study is that it is prospective and multicenter. “It has been supported by other past studies as well and will define for which patients with newly treated breast cancers can we omit radiation, which has been the standard of care,” said Dr. Axelrod. “It is based on the age and biology of breast cancer in defining which patient can forgo radiation and showed a low risk of recurrence in a specific population of women with a favorable breast cancer profile”
There were limitations to the study. “There is a 5-year follow-up and local recurrence for ER-positive cancers continues to rise after 5 years, so longer-term follow-up will be important,” she said. Also, she pointed out that it is a single-arm study so there is no radiation therapy comparison arm.
Other limitations were that the patients were older with smaller tumors, and all were committed to 5 years of endocrine therapy, although compliance with that has not been reported. There may be some older patients who prefer radiation therapy, especially a week of accelerated partial breast irradiation, rather than commit to 5 years of endocrine therapy as mandated in this study.
“Overall, the takeaway message for patients is that the omission of radiation therapy should be considered an option for older women with localized breast cancer with favorable features who receive endocrine therapies,” said Dr. Axelrod.
LUMINA was sponsored by the Canadian Breast Cancer Foundation and the Canadian Cancer Society. Dr. Whelan has reported research funding from Exact Sciences (Inst). Dr. Axelrod and Dr. Anderson reported no disclosures. Dr. Gralow reported relationships with Genentech, AstraZeneca, Hexal, Puma BioTechnology, Roche, Novartis, Seagen, and Genomic Health.
A version of this article first appeared on Medscape.com.
FROM ASCO 2022
Many sources of PTSD are cause for concern
A few weeks ago, right after 19 children and two adults were killed by a gunman in Uvalde, Texas, Americans were really on edge. Many people I know became hypervigilant while going about activities previously thought of as routine, such as waiting for a subway or going to a grocery store.
On top of that, we are still facing the ongoing COVID-19 pandemic. Despite vaccines and therapeutics, the United States is still losing more than 300 people each day to the virus. Many people who have tested positive have continued to experience debilitating long-haul symptoms many months after testing negative, and I believe not knowing what your future life will bring from this terrible illness could lead some to posttraumatic stress disorder.
In addition to constant updates about COVID, we are getting almost daily reports about monkeypox. In New York state, medical professionals and institutions receive regular, almost weekly, information about the spread of influenza. But where are the reports and treatment approaches for PTSD, which would not only increase awareness but also lead to more care?
Some might believe that I am obsessed with PTSD, since I’ve written a great deal on the subject, particularly “underdiagnosed” PTSD. The key question I have is:
We know the signs and symptoms of PTSD. They include flashbacks, intrusive recollections, physical distress related to stimuli related to the trauma, insomnia, social isolation, avoidance of certain situations, negative thinking, and hyperarousal – coupled with anxiety and depression. PTSD can be a great masquerader. It can be triggered by many events, large and small, and all too often will masquerade as general anxiety or existential despair and depression. Too often, PTSD is undiagnosed or unrecognized completely. PTSD is also a costly disease that is an enormous economic burden on the U.S. economy.
As clinicians, we must be aware of the more subtle events that may trigger PTSD. We must think beyond ICD codes and DSM criteria and realize that each individual processes an event or a series of events differently. For example, seriously ill people in ICUs or undergoing critical care have been known to experience PTSD well beyond their physical recovery (J Crit Care. 2017 Dec. doi: 10.1016/j.jcrc.2017.06.014). Years after the Sept. 11, 2001, World Trade Center disaster, many are still suffering from PTSD symptoms (Biol Psychiatry. 2020 May 1. doi: 10.1016/j.biopsych.2020.02.817).
Again, in some cases, not knowing what the future may bring regarding life itself can lead to PTSD. I have treated patients who have lost jobs and experienced devastating social and financial losses, which were perceived as a separation from “life as they know it.” These can be precursors to PTSD for some who are sensitive to the disorder.
Intergenerational trauma is also a real phenomenon to which we must be attuned. I have treated two adult children of Holocaust survivors, both born in America well after World War II, who developed PTSD after hearing family recollections over and over about the brutality suffered by relatives, combined with watching films about people sent to concentration camps. Both of those patients self-diagnosed their symptoms as depression. Research shows that Holocaust traumatization can affect three generations (J Anxiety Disord. 2021 Jun. doi: 10.1016/j.janxdis.2021.102401).
In light of the high incidence of traumatic events affecting millions directly, more codified treatment approaches are needed that can be used both for individuals and for those in group settings.
To date, the best treatment rests with cognitive-behavioral therapy (CBT) and guided imagery coupled with relaxation techniques and the various types of in vivo exposure therapy, which I prefer to in vitro or flooding care. In terms of medication management, the U.S. Food and Drug Administration has approved only two antidepressant medications for PTSD, sertraline (Zoloft) and paroxetine (Paxil), although other selective serotonin reuptake inhibitors have been used off- label, and prazosin, a hypertensive medication, has been used off-label for PTSD-related insomnia and nightmares (Prim Care Companion CNS Disord. 2012 Mar 22. doi: 10.4088/PCC.11r01222). Thus, the limited number of choices for medication management means more research is needed so that more medications are developed that are more precisely directed at PTSD treatment.
Implications for society at large
In a recent article published in the Journal of Clinical Psychiatry (2022 Apr 25. doi: 10.4088/JCP.21m14116), authors Lori L. Davis and colleagues point out that the economic burden of PTSD goes beyond health care costs and rivals the costs of other mental illnesses, including depression and anxiety. In the process, Dr. Davis and colleagues note, unemployment caused by job loss, disability, homelessness, substance use, disordered care, as well as premature mortality, all contribute to this severe burden, going beyond PTSD itself.
This study shows that the annual economic burden of PTSD is $232 billion. Most of that burden is attributed to the civilian population, which they suggest to be $189.5 billion, or 82%.
After reading that article, it became clear to me that my “obsession” with PTSD is not really an obsession at all. Rather, it is a true concern that, against the backdrop of long COVID, gun violence, political and economic turmoil, and other factors, it is important that clinicians understand how to recognize and treat PTSD. The stakes have never been higher.
Dr. London is a practicing psychiatrist and has been a newspaper columnist for 35 years, specializing in and writing about short-term therapy, including cognitive-behavioral therapy and guided imagery. He is author of “Find Freedom Fast” (New York: Kettlehole Publishing, 2019). He has no conflicts of interest.
A few weeks ago, right after 19 children and two adults were killed by a gunman in Uvalde, Texas, Americans were really on edge. Many people I know became hypervigilant while going about activities previously thought of as routine, such as waiting for a subway or going to a grocery store.
On top of that, we are still facing the ongoing COVID-19 pandemic. Despite vaccines and therapeutics, the United States is still losing more than 300 people each day to the virus. Many people who have tested positive have continued to experience debilitating long-haul symptoms many months after testing negative, and I believe not knowing what your future life will bring from this terrible illness could lead some to posttraumatic stress disorder.
In addition to constant updates about COVID, we are getting almost daily reports about monkeypox. In New York state, medical professionals and institutions receive regular, almost weekly, information about the spread of influenza. But where are the reports and treatment approaches for PTSD, which would not only increase awareness but also lead to more care?
Some might believe that I am obsessed with PTSD, since I’ve written a great deal on the subject, particularly “underdiagnosed” PTSD. The key question I have is:
We know the signs and symptoms of PTSD. They include flashbacks, intrusive recollections, physical distress related to stimuli related to the trauma, insomnia, social isolation, avoidance of certain situations, negative thinking, and hyperarousal – coupled with anxiety and depression. PTSD can be a great masquerader. It can be triggered by many events, large and small, and all too often will masquerade as general anxiety or existential despair and depression. Too often, PTSD is undiagnosed or unrecognized completely. PTSD is also a costly disease that is an enormous economic burden on the U.S. economy.
As clinicians, we must be aware of the more subtle events that may trigger PTSD. We must think beyond ICD codes and DSM criteria and realize that each individual processes an event or a series of events differently. For example, seriously ill people in ICUs or undergoing critical care have been known to experience PTSD well beyond their physical recovery (J Crit Care. 2017 Dec. doi: 10.1016/j.jcrc.2017.06.014). Years after the Sept. 11, 2001, World Trade Center disaster, many are still suffering from PTSD symptoms (Biol Psychiatry. 2020 May 1. doi: 10.1016/j.biopsych.2020.02.817).
Again, in some cases, not knowing what the future may bring regarding life itself can lead to PTSD. I have treated patients who have lost jobs and experienced devastating social and financial losses, which were perceived as a separation from “life as they know it.” These can be precursors to PTSD for some who are sensitive to the disorder.
Intergenerational trauma is also a real phenomenon to which we must be attuned. I have treated two adult children of Holocaust survivors, both born in America well after World War II, who developed PTSD after hearing family recollections over and over about the brutality suffered by relatives, combined with watching films about people sent to concentration camps. Both of those patients self-diagnosed their symptoms as depression. Research shows that Holocaust traumatization can affect three generations (J Anxiety Disord. 2021 Jun. doi: 10.1016/j.janxdis.2021.102401).
In light of the high incidence of traumatic events affecting millions directly, more codified treatment approaches are needed that can be used both for individuals and for those in group settings.
To date, the best treatment rests with cognitive-behavioral therapy (CBT) and guided imagery coupled with relaxation techniques and the various types of in vivo exposure therapy, which I prefer to in vitro or flooding care. In terms of medication management, the U.S. Food and Drug Administration has approved only two antidepressant medications for PTSD, sertraline (Zoloft) and paroxetine (Paxil), although other selective serotonin reuptake inhibitors have been used off- label, and prazosin, a hypertensive medication, has been used off-label for PTSD-related insomnia and nightmares (Prim Care Companion CNS Disord. 2012 Mar 22. doi: 10.4088/PCC.11r01222). Thus, the limited number of choices for medication management means more research is needed so that more medications are developed that are more precisely directed at PTSD treatment.
Implications for society at large
In a recent article published in the Journal of Clinical Psychiatry (2022 Apr 25. doi: 10.4088/JCP.21m14116), authors Lori L. Davis and colleagues point out that the economic burden of PTSD goes beyond health care costs and rivals the costs of other mental illnesses, including depression and anxiety. In the process, Dr. Davis and colleagues note, unemployment caused by job loss, disability, homelessness, substance use, disordered care, as well as premature mortality, all contribute to this severe burden, going beyond PTSD itself.
This study shows that the annual economic burden of PTSD is $232 billion. Most of that burden is attributed to the civilian population, which they suggest to be $189.5 billion, or 82%.
After reading that article, it became clear to me that my “obsession” with PTSD is not really an obsession at all. Rather, it is a true concern that, against the backdrop of long COVID, gun violence, political and economic turmoil, and other factors, it is important that clinicians understand how to recognize and treat PTSD. The stakes have never been higher.
Dr. London is a practicing psychiatrist and has been a newspaper columnist for 35 years, specializing in and writing about short-term therapy, including cognitive-behavioral therapy and guided imagery. He is author of “Find Freedom Fast” (New York: Kettlehole Publishing, 2019). He has no conflicts of interest.
A few weeks ago, right after 19 children and two adults were killed by a gunman in Uvalde, Texas, Americans were really on edge. Many people I know became hypervigilant while going about activities previously thought of as routine, such as waiting for a subway or going to a grocery store.
On top of that, we are still facing the ongoing COVID-19 pandemic. Despite vaccines and therapeutics, the United States is still losing more than 300 people each day to the virus. Many people who have tested positive have continued to experience debilitating long-haul symptoms many months after testing negative, and I believe not knowing what your future life will bring from this terrible illness could lead some to posttraumatic stress disorder.
In addition to constant updates about COVID, we are getting almost daily reports about monkeypox. In New York state, medical professionals and institutions receive regular, almost weekly, information about the spread of influenza. But where are the reports and treatment approaches for PTSD, which would not only increase awareness but also lead to more care?
Some might believe that I am obsessed with PTSD, since I’ve written a great deal on the subject, particularly “underdiagnosed” PTSD. The key question I have is:
We know the signs and symptoms of PTSD. They include flashbacks, intrusive recollections, physical distress related to stimuli related to the trauma, insomnia, social isolation, avoidance of certain situations, negative thinking, and hyperarousal – coupled with anxiety and depression. PTSD can be a great masquerader. It can be triggered by many events, large and small, and all too often will masquerade as general anxiety or existential despair and depression. Too often, PTSD is undiagnosed or unrecognized completely. PTSD is also a costly disease that is an enormous economic burden on the U.S. economy.
As clinicians, we must be aware of the more subtle events that may trigger PTSD. We must think beyond ICD codes and DSM criteria and realize that each individual processes an event or a series of events differently. For example, seriously ill people in ICUs or undergoing critical care have been known to experience PTSD well beyond their physical recovery (J Crit Care. 2017 Dec. doi: 10.1016/j.jcrc.2017.06.014). Years after the Sept. 11, 2001, World Trade Center disaster, many are still suffering from PTSD symptoms (Biol Psychiatry. 2020 May 1. doi: 10.1016/j.biopsych.2020.02.817).
Again, in some cases, not knowing what the future may bring regarding life itself can lead to PTSD. I have treated patients who have lost jobs and experienced devastating social and financial losses, which were perceived as a separation from “life as they know it.” These can be precursors to PTSD for some who are sensitive to the disorder.
Intergenerational trauma is also a real phenomenon to which we must be attuned. I have treated two adult children of Holocaust survivors, both born in America well after World War II, who developed PTSD after hearing family recollections over and over about the brutality suffered by relatives, combined with watching films about people sent to concentration camps. Both of those patients self-diagnosed their symptoms as depression. Research shows that Holocaust traumatization can affect three generations (J Anxiety Disord. 2021 Jun. doi: 10.1016/j.janxdis.2021.102401).
In light of the high incidence of traumatic events affecting millions directly, more codified treatment approaches are needed that can be used both for individuals and for those in group settings.
To date, the best treatment rests with cognitive-behavioral therapy (CBT) and guided imagery coupled with relaxation techniques and the various types of in vivo exposure therapy, which I prefer to in vitro or flooding care. In terms of medication management, the U.S. Food and Drug Administration has approved only two antidepressant medications for PTSD, sertraline (Zoloft) and paroxetine (Paxil), although other selective serotonin reuptake inhibitors have been used off- label, and prazosin, a hypertensive medication, has been used off-label for PTSD-related insomnia and nightmares (Prim Care Companion CNS Disord. 2012 Mar 22. doi: 10.4088/PCC.11r01222). Thus, the limited number of choices for medication management means more research is needed so that more medications are developed that are more precisely directed at PTSD treatment.
Implications for society at large
In a recent article published in the Journal of Clinical Psychiatry (2022 Apr 25. doi: 10.4088/JCP.21m14116), authors Lori L. Davis and colleagues point out that the economic burden of PTSD goes beyond health care costs and rivals the costs of other mental illnesses, including depression and anxiety. In the process, Dr. Davis and colleagues note, unemployment caused by job loss, disability, homelessness, substance use, disordered care, as well as premature mortality, all contribute to this severe burden, going beyond PTSD itself.
This study shows that the annual economic burden of PTSD is $232 billion. Most of that burden is attributed to the civilian population, which they suggest to be $189.5 billion, or 82%.
After reading that article, it became clear to me that my “obsession” with PTSD is not really an obsession at all. Rather, it is a true concern that, against the backdrop of long COVID, gun violence, political and economic turmoil, and other factors, it is important that clinicians understand how to recognize and treat PTSD. The stakes have never been higher.
Dr. London is a practicing psychiatrist and has been a newspaper columnist for 35 years, specializing in and writing about short-term therapy, including cognitive-behavioral therapy and guided imagery. He is author of “Find Freedom Fast” (New York: Kettlehole Publishing, 2019). He has no conflicts of interest.
Eczema causes substantial burden for many infants and preschoolers
INDIANAPOLIS – . Those are key findings from a large international web-based survey that was presented during a poster session at the annual meeting of the Society for Pediatric Dermatology.
“Improved knowledge of the AD-related burden may help reinforce the medical need in the pediatric population and contribute to better and earlier adequate management of the disease,” authors led by Stephan Weidinger , MD, PhD, vice head of the department of dermatology at University Hospital Schleswig-Holstein, Kiel, Germany, wrote in the abstract.
For the study, Dr. Weidinger and colleagues evaluated 1,486 infants and preschoolers with AD aged 6 months to under 6 years, who participated in the Epidemiology of Children with Atopic Dermatitis Reporting on their Experience (EPI-CARE), an international, cross-sectional, web-based survey of children and adolescents. The study population resided in 18 countries from five regions of the world, including North America, Latin America, Europe, Middle East/Eurasia, and East Asia. Parents or guardians answered all questions for infants/preschoolers younger than 4 years of age, while preschoolers aged 4 to younger than 6 years were asked to answer questions related to the impact of AD on their health-related quality of life.
AD severity was assessed using Patient Global Assessment (PtGA), where parents or guardians described their child’s eczema severity over the last week as mild, moderate, or severe. The researchers stratified outcomes by geographic region and AD severity, which included the following atopic comorbidities: worst itch, worst skin pain, and overall sleep disturbance in the past 24 hours as measured by the 0-10 numeric rating scale, where higher scores indicate worse severity; eczema-related hospitalization in the past 12 months; and frequency and average duration of flares over the past month.
The mean age of the study participants was 3 years and 61.6% had mild disease. The most common atopic comorbidities were hay fever, asthma, and seasonal allergies, and the incidence of atopic comorbidities increased with increasing AD severity. One or more atopic comorbidities was reported in 88.3% of patients with mild AD, compared with 92.1% of those with moderate disease and 95.8% of those with severe disease. In addition, infants and preschoolers with moderate or severe AD had worse itch, skin pain, and sleep disturbances over the past 24 hours, compared with those who had mild AD.
More than half of infants and preschoolers with severe AD (54.1%) were reported to have been hospitalized in the past 12 months (this ranged from 30.2% to 71.3% across regions), as did 35% of patients with moderate AD and 32.1% of those with mild AD. In addition, 50.6% of infants and preschoolers with severe AD had more than two flares in the past month, compared with 18.1% of those with moderate AD and 6.3% of those with mild disease.
In other findings, 50.7% of infants and preschoolers with severe AD had flares than lasted an average of 2 or more weeks, compared with 20.8% of those with moderate disease and 10% of those with mild disease. Also, 78.3% of preschoolers aged 4 to less than 6 years had missed one or more days of school in the previous 4 weeks: a mean of 5.1 days among those with mild AD, a mean of 7.3 days among those with moderate AD, and a mean of 12.1 days among those with severe disease.
Raj J. Chovatiya MD, PhD, of the department of dermatology at Northwestern University, Chicago, who was asked to comment on the study, said that infants and preschoolers remain an understudied group despite the high prevalence of AD in this age range. “The results of this study demonstrate a substantial burden of disease in this population, particularly among those with more severe disease,” said Dr. Chovatiya, who also directs the university’s Center for Eczema and Itch. “This includes longer and more frequent AD flares as well as high rates of inpatient hospitalization. These findings suggest that additional research is needed to better characterize disease burden and optimize outcomes for young children with AD.”
The study was funded by Regeneron Pharmaceuticals and Sanofi. Dr. Weidinger and other coauthors reported having received institutional research grants and consulting fees from many pharmaceutical companies that manufacture drugs used for the treatment of psoriasis and eczema.
Dr. Chovatiya disclosed that he has served as an advisory board member, consultant, speaker, and/or investigator for AbbVie, Arcutis, Arena, Beiersdorf, Bristol Myers Squibb, Dermavant, Eli Lilly, EPI Health, Incyte, L’Oréal, the National Eczema Association, Pfizer, Regeneron, Sanofi, and UCB.
INDIANAPOLIS – . Those are key findings from a large international web-based survey that was presented during a poster session at the annual meeting of the Society for Pediatric Dermatology.
“Improved knowledge of the AD-related burden may help reinforce the medical need in the pediatric population and contribute to better and earlier adequate management of the disease,” authors led by Stephan Weidinger , MD, PhD, vice head of the department of dermatology at University Hospital Schleswig-Holstein, Kiel, Germany, wrote in the abstract.
For the study, Dr. Weidinger and colleagues evaluated 1,486 infants and preschoolers with AD aged 6 months to under 6 years, who participated in the Epidemiology of Children with Atopic Dermatitis Reporting on their Experience (EPI-CARE), an international, cross-sectional, web-based survey of children and adolescents. The study population resided in 18 countries from five regions of the world, including North America, Latin America, Europe, Middle East/Eurasia, and East Asia. Parents or guardians answered all questions for infants/preschoolers younger than 4 years of age, while preschoolers aged 4 to younger than 6 years were asked to answer questions related to the impact of AD on their health-related quality of life.
AD severity was assessed using Patient Global Assessment (PtGA), where parents or guardians described their child’s eczema severity over the last week as mild, moderate, or severe. The researchers stratified outcomes by geographic region and AD severity, which included the following atopic comorbidities: worst itch, worst skin pain, and overall sleep disturbance in the past 24 hours as measured by the 0-10 numeric rating scale, where higher scores indicate worse severity; eczema-related hospitalization in the past 12 months; and frequency and average duration of flares over the past month.
The mean age of the study participants was 3 years and 61.6% had mild disease. The most common atopic comorbidities were hay fever, asthma, and seasonal allergies, and the incidence of atopic comorbidities increased with increasing AD severity. One or more atopic comorbidities was reported in 88.3% of patients with mild AD, compared with 92.1% of those with moderate disease and 95.8% of those with severe disease. In addition, infants and preschoolers with moderate or severe AD had worse itch, skin pain, and sleep disturbances over the past 24 hours, compared with those who had mild AD.
More than half of infants and preschoolers with severe AD (54.1%) were reported to have been hospitalized in the past 12 months (this ranged from 30.2% to 71.3% across regions), as did 35% of patients with moderate AD and 32.1% of those with mild AD. In addition, 50.6% of infants and preschoolers with severe AD had more than two flares in the past month, compared with 18.1% of those with moderate AD and 6.3% of those with mild disease.
In other findings, 50.7% of infants and preschoolers with severe AD had flares than lasted an average of 2 or more weeks, compared with 20.8% of those with moderate disease and 10% of those with mild disease. Also, 78.3% of preschoolers aged 4 to less than 6 years had missed one or more days of school in the previous 4 weeks: a mean of 5.1 days among those with mild AD, a mean of 7.3 days among those with moderate AD, and a mean of 12.1 days among those with severe disease.
Raj J. Chovatiya MD, PhD, of the department of dermatology at Northwestern University, Chicago, who was asked to comment on the study, said that infants and preschoolers remain an understudied group despite the high prevalence of AD in this age range. “The results of this study demonstrate a substantial burden of disease in this population, particularly among those with more severe disease,” said Dr. Chovatiya, who also directs the university’s Center for Eczema and Itch. “This includes longer and more frequent AD flares as well as high rates of inpatient hospitalization. These findings suggest that additional research is needed to better characterize disease burden and optimize outcomes for young children with AD.”
The study was funded by Regeneron Pharmaceuticals and Sanofi. Dr. Weidinger and other coauthors reported having received institutional research grants and consulting fees from many pharmaceutical companies that manufacture drugs used for the treatment of psoriasis and eczema.
Dr. Chovatiya disclosed that he has served as an advisory board member, consultant, speaker, and/or investigator for AbbVie, Arcutis, Arena, Beiersdorf, Bristol Myers Squibb, Dermavant, Eli Lilly, EPI Health, Incyte, L’Oréal, the National Eczema Association, Pfizer, Regeneron, Sanofi, and UCB.
INDIANAPOLIS – . Those are key findings from a large international web-based survey that was presented during a poster session at the annual meeting of the Society for Pediatric Dermatology.
“Improved knowledge of the AD-related burden may help reinforce the medical need in the pediatric population and contribute to better and earlier adequate management of the disease,” authors led by Stephan Weidinger , MD, PhD, vice head of the department of dermatology at University Hospital Schleswig-Holstein, Kiel, Germany, wrote in the abstract.
For the study, Dr. Weidinger and colleagues evaluated 1,486 infants and preschoolers with AD aged 6 months to under 6 years, who participated in the Epidemiology of Children with Atopic Dermatitis Reporting on their Experience (EPI-CARE), an international, cross-sectional, web-based survey of children and adolescents. The study population resided in 18 countries from five regions of the world, including North America, Latin America, Europe, Middle East/Eurasia, and East Asia. Parents or guardians answered all questions for infants/preschoolers younger than 4 years of age, while preschoolers aged 4 to younger than 6 years were asked to answer questions related to the impact of AD on their health-related quality of life.
AD severity was assessed using Patient Global Assessment (PtGA), where parents or guardians described their child’s eczema severity over the last week as mild, moderate, or severe. The researchers stratified outcomes by geographic region and AD severity, which included the following atopic comorbidities: worst itch, worst skin pain, and overall sleep disturbance in the past 24 hours as measured by the 0-10 numeric rating scale, where higher scores indicate worse severity; eczema-related hospitalization in the past 12 months; and frequency and average duration of flares over the past month.
The mean age of the study participants was 3 years and 61.6% had mild disease. The most common atopic comorbidities were hay fever, asthma, and seasonal allergies, and the incidence of atopic comorbidities increased with increasing AD severity. One or more atopic comorbidities was reported in 88.3% of patients with mild AD, compared with 92.1% of those with moderate disease and 95.8% of those with severe disease. In addition, infants and preschoolers with moderate or severe AD had worse itch, skin pain, and sleep disturbances over the past 24 hours, compared with those who had mild AD.
More than half of infants and preschoolers with severe AD (54.1%) were reported to have been hospitalized in the past 12 months (this ranged from 30.2% to 71.3% across regions), as did 35% of patients with moderate AD and 32.1% of those with mild AD. In addition, 50.6% of infants and preschoolers with severe AD had more than two flares in the past month, compared with 18.1% of those with moderate AD and 6.3% of those with mild disease.
In other findings, 50.7% of infants and preschoolers with severe AD had flares than lasted an average of 2 or more weeks, compared with 20.8% of those with moderate disease and 10% of those with mild disease. Also, 78.3% of preschoolers aged 4 to less than 6 years had missed one or more days of school in the previous 4 weeks: a mean of 5.1 days among those with mild AD, a mean of 7.3 days among those with moderate AD, and a mean of 12.1 days among those with severe disease.
Raj J. Chovatiya MD, PhD, of the department of dermatology at Northwestern University, Chicago, who was asked to comment on the study, said that infants and preschoolers remain an understudied group despite the high prevalence of AD in this age range. “The results of this study demonstrate a substantial burden of disease in this population, particularly among those with more severe disease,” said Dr. Chovatiya, who also directs the university’s Center for Eczema and Itch. “This includes longer and more frequent AD flares as well as high rates of inpatient hospitalization. These findings suggest that additional research is needed to better characterize disease burden and optimize outcomes for young children with AD.”
The study was funded by Regeneron Pharmaceuticals and Sanofi. Dr. Weidinger and other coauthors reported having received institutional research grants and consulting fees from many pharmaceutical companies that manufacture drugs used for the treatment of psoriasis and eczema.
Dr. Chovatiya disclosed that he has served as an advisory board member, consultant, speaker, and/or investigator for AbbVie, Arcutis, Arena, Beiersdorf, Bristol Myers Squibb, Dermavant, Eli Lilly, EPI Health, Incyte, L’Oréal, the National Eczema Association, Pfizer, Regeneron, Sanofi, and UCB.
AT SPD 2022
Gender surgeons on TikTok, Instagram: Appropriate or not?
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.
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.
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.
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.