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FDA to step up oversight of cosmetics, assess ‘forever chemicals’
They are also preparing to assess potential risks of so-called forever chemicals in these products.
The Food and Drug Administration last year gained new authority over cosmetics when Congress passed the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) by adding this bill to a December budget package.
“On average, consumers in the U.S. use six to 12 cosmetics products daily. But, until recently the FDA didn’t have the authority to require manufacturers to submit cosmetic product listings, including a list of ingredients used in these products, or register the facilities where they were produced,” Namandjé Bumpus, PhD, FDA’s chief scientist, said in a press release.
In the statement, the FDA announced the release of a draft guidance document that is intended to help companies comply with the transparency requirements slated to kick in this December. The agency is accepting comments on this draft guidance through Sept. 7.
“Later this year, registration and listing of cosmetic product facilities and products will become a requirement, making information about cosmetic products, including the ingredients used in products and the facilities where they are produced, readily available to the agency,” Dr. Bumpus said.
The products, according to the FDA statement, include makeup, nail polishes, shaving creams, other grooming products, perfumes, face and body cleansers, hair products, moisturizers, and other skin care items.
MoCRA “represents a sea change in how FDA regulates the cosmetics industry,” attorneys Frederick R. Ball, Alyson Walker Lotman, and Kelly A. Bonner, wrote in an article for the Food and Drug Law Institute published in spring 2023.
The FDA has called the MoCRA law “the most significant expansion” of its authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act was passed in 1938.
The agency is in the process of expanding its staff to carry out newly authorized duties, including the tracking of adverse events. The FDA budget request for fiscal 2024, which begins Oct. 1, seeks $5 million for work needed to implement MoCRA.
PFAS, or ‘forever chemicals’
Some of the requested FDA funding is intended to prepare the agency to assess the use of per-and polyfluoroalkyl substances (PFAS) in cosmetics.
MoCRA sets a 3-year deadline for the FDA to issue an assessment of the use and potential risks of PFAS in cosmetics products. PFAS are sometimes added as ingredients in some cosmetic products, including lotions, cleansers, nail polish, shaving cream, foundation, lipstick, eyeliner, eyeshadow, and mascara, according to the FDA. Sometimes the presence of PFAS in cosmetics is unintentional and is the result of impurities in raw materials or is due to the breakdown of ingredients, the FDA said.
The FDA’s website says that so far, the available research doesn’t allow for “definitive conclusions about the potential health risks of PFAS in cosmetics.”
The Centers for Disease Control and Prevention has stated that research has suggested potential links between high levels of certain PFAS, in general, with increased cholesterol levels, changes in liver enzyme levels, increased risk of hypertension or preeclampsia in pregnant women, and increased risk of kidney or testicular cancer.
PFAS compounds often are used to resist grease, oil, water, and heat in industrial settings. They are used in thousands of products, from nonstick cookware to firefighting foams and protective gear, because they can reduce friction, according to a National Academies of Sciences, Engineering, and Medicine report on PFAS that was issued last year.
PFAS are known as “forever chemicals” because they contain a carbon-fluorine bond, which does not break naturally. Even when PFAS are transformed in the body, they can assume other forms of PFAS that preserve the troublesome carbon-fluorine bond. With PFAS, the human body is confronted with a substance it doesn’t have the tools to process.
This is in contrast to proteins and carbohydrates, which are in a sense prepackaged for relatively easy disassembly in the human body. Many of these compounds have weak links that enzymes and stomach acid can take apart, such as sulfur-to-sulfur (disulfide) bonds. That’s why protein-based biotech drugs are injected instead of administered as pills. The ultimate goal of this digestion is for the body to gain energy from these compounds.
But with PFAS, the body faces the challenge of carbon-fluorine bonds that are very hard to break down, and there is no payoff for these efforts, Graham F. Peaslee, PhD, professor of physics at the University of Notre Dame (Indiana), told this news organization.
“Nothing will naturally eat it because when you break the bond, it’s like eating celery,” he said. “You use more calories to eat the celery than you gain back from it.”
Interest from a U.S. senator
Dr. Peaslee was one of the authors of a 2021 article about PFAS in cosmetics that appeared in the journal Environmental Science and Technology Letters.
In the article, Dr. Peaslee and colleagues reported on their screening of 231 cosmetic products purchased in the United States and Canada using particle-induced gamma-ray emission spectroscopy. They found cases of undisclosed PFAS in cosmetic products. Foundations, mascaras, and lip products were noted as being especially problematic.
Sen. Susan Collins (R-ME) cited Dr. Peaslee’s article in a 2021 floor speech as she argued for having the FDA ban the intentional addition of PFAS to cosmetics.
“The findings of this study are particularly alarming, as many of these products are subject to direct human exposure,” Sen. Collins said. “For example, lipstick is often inadvertently ingested, and mascara is sometimes absorbed through tear ducts.”
In addition, workers at cosmetics plants may be exposed to PFAS and discarded cosmetics that have these compounds, which could potentially contaminate drinking water, Sen. Collins said. In 2021, she introduced legislation seeking a ban on PFAS that are intentionally added to cosmetics. That legislation did not advance through the Senate.
But the Senate Appropriations Committee, on which Sen. Collins is the ranking Republican, wants the FDA to keep a ban on PFAS in mind.
The Senate Agriculture Appropriations subcommittee, which oversees the FDA’s budget, raised the issue of PFAS and cosmetics in a June report. The FDA should develop a plan outlining research needed to inform “regulatory decision making, including potential development of a proposed rule to ban intentionally added PFAS substances in cosmetics,” the subcommittee said.
A version of this article first appeared on Medscape.com.
They are also preparing to assess potential risks of so-called forever chemicals in these products.
The Food and Drug Administration last year gained new authority over cosmetics when Congress passed the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) by adding this bill to a December budget package.
“On average, consumers in the U.S. use six to 12 cosmetics products daily. But, until recently the FDA didn’t have the authority to require manufacturers to submit cosmetic product listings, including a list of ingredients used in these products, or register the facilities where they were produced,” Namandjé Bumpus, PhD, FDA’s chief scientist, said in a press release.
In the statement, the FDA announced the release of a draft guidance document that is intended to help companies comply with the transparency requirements slated to kick in this December. The agency is accepting comments on this draft guidance through Sept. 7.
“Later this year, registration and listing of cosmetic product facilities and products will become a requirement, making information about cosmetic products, including the ingredients used in products and the facilities where they are produced, readily available to the agency,” Dr. Bumpus said.
The products, according to the FDA statement, include makeup, nail polishes, shaving creams, other grooming products, perfumes, face and body cleansers, hair products, moisturizers, and other skin care items.
MoCRA “represents a sea change in how FDA regulates the cosmetics industry,” attorneys Frederick R. Ball, Alyson Walker Lotman, and Kelly A. Bonner, wrote in an article for the Food and Drug Law Institute published in spring 2023.
The FDA has called the MoCRA law “the most significant expansion” of its authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act was passed in 1938.
The agency is in the process of expanding its staff to carry out newly authorized duties, including the tracking of adverse events. The FDA budget request for fiscal 2024, which begins Oct. 1, seeks $5 million for work needed to implement MoCRA.
PFAS, or ‘forever chemicals’
Some of the requested FDA funding is intended to prepare the agency to assess the use of per-and polyfluoroalkyl substances (PFAS) in cosmetics.
MoCRA sets a 3-year deadline for the FDA to issue an assessment of the use and potential risks of PFAS in cosmetics products. PFAS are sometimes added as ingredients in some cosmetic products, including lotions, cleansers, nail polish, shaving cream, foundation, lipstick, eyeliner, eyeshadow, and mascara, according to the FDA. Sometimes the presence of PFAS in cosmetics is unintentional and is the result of impurities in raw materials or is due to the breakdown of ingredients, the FDA said.
The FDA’s website says that so far, the available research doesn’t allow for “definitive conclusions about the potential health risks of PFAS in cosmetics.”
The Centers for Disease Control and Prevention has stated that research has suggested potential links between high levels of certain PFAS, in general, with increased cholesterol levels, changes in liver enzyme levels, increased risk of hypertension or preeclampsia in pregnant women, and increased risk of kidney or testicular cancer.
PFAS compounds often are used to resist grease, oil, water, and heat in industrial settings. They are used in thousands of products, from nonstick cookware to firefighting foams and protective gear, because they can reduce friction, according to a National Academies of Sciences, Engineering, and Medicine report on PFAS that was issued last year.
PFAS are known as “forever chemicals” because they contain a carbon-fluorine bond, which does not break naturally. Even when PFAS are transformed in the body, they can assume other forms of PFAS that preserve the troublesome carbon-fluorine bond. With PFAS, the human body is confronted with a substance it doesn’t have the tools to process.
This is in contrast to proteins and carbohydrates, which are in a sense prepackaged for relatively easy disassembly in the human body. Many of these compounds have weak links that enzymes and stomach acid can take apart, such as sulfur-to-sulfur (disulfide) bonds. That’s why protein-based biotech drugs are injected instead of administered as pills. The ultimate goal of this digestion is for the body to gain energy from these compounds.
But with PFAS, the body faces the challenge of carbon-fluorine bonds that are very hard to break down, and there is no payoff for these efforts, Graham F. Peaslee, PhD, professor of physics at the University of Notre Dame (Indiana), told this news organization.
“Nothing will naturally eat it because when you break the bond, it’s like eating celery,” he said. “You use more calories to eat the celery than you gain back from it.”
Interest from a U.S. senator
Dr. Peaslee was one of the authors of a 2021 article about PFAS in cosmetics that appeared in the journal Environmental Science and Technology Letters.
In the article, Dr. Peaslee and colleagues reported on their screening of 231 cosmetic products purchased in the United States and Canada using particle-induced gamma-ray emission spectroscopy. They found cases of undisclosed PFAS in cosmetic products. Foundations, mascaras, and lip products were noted as being especially problematic.
Sen. Susan Collins (R-ME) cited Dr. Peaslee’s article in a 2021 floor speech as she argued for having the FDA ban the intentional addition of PFAS to cosmetics.
“The findings of this study are particularly alarming, as many of these products are subject to direct human exposure,” Sen. Collins said. “For example, lipstick is often inadvertently ingested, and mascara is sometimes absorbed through tear ducts.”
In addition, workers at cosmetics plants may be exposed to PFAS and discarded cosmetics that have these compounds, which could potentially contaminate drinking water, Sen. Collins said. In 2021, she introduced legislation seeking a ban on PFAS that are intentionally added to cosmetics. That legislation did not advance through the Senate.
But the Senate Appropriations Committee, on which Sen. Collins is the ranking Republican, wants the FDA to keep a ban on PFAS in mind.
The Senate Agriculture Appropriations subcommittee, which oversees the FDA’s budget, raised the issue of PFAS and cosmetics in a June report. The FDA should develop a plan outlining research needed to inform “regulatory decision making, including potential development of a proposed rule to ban intentionally added PFAS substances in cosmetics,” the subcommittee said.
A version of this article first appeared on Medscape.com.
They are also preparing to assess potential risks of so-called forever chemicals in these products.
The Food and Drug Administration last year gained new authority over cosmetics when Congress passed the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) by adding this bill to a December budget package.
“On average, consumers in the U.S. use six to 12 cosmetics products daily. But, until recently the FDA didn’t have the authority to require manufacturers to submit cosmetic product listings, including a list of ingredients used in these products, or register the facilities where they were produced,” Namandjé Bumpus, PhD, FDA’s chief scientist, said in a press release.
In the statement, the FDA announced the release of a draft guidance document that is intended to help companies comply with the transparency requirements slated to kick in this December. The agency is accepting comments on this draft guidance through Sept. 7.
“Later this year, registration and listing of cosmetic product facilities and products will become a requirement, making information about cosmetic products, including the ingredients used in products and the facilities where they are produced, readily available to the agency,” Dr. Bumpus said.
The products, according to the FDA statement, include makeup, nail polishes, shaving creams, other grooming products, perfumes, face and body cleansers, hair products, moisturizers, and other skin care items.
MoCRA “represents a sea change in how FDA regulates the cosmetics industry,” attorneys Frederick R. Ball, Alyson Walker Lotman, and Kelly A. Bonner, wrote in an article for the Food and Drug Law Institute published in spring 2023.
The FDA has called the MoCRA law “the most significant expansion” of its authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act was passed in 1938.
The agency is in the process of expanding its staff to carry out newly authorized duties, including the tracking of adverse events. The FDA budget request for fiscal 2024, which begins Oct. 1, seeks $5 million for work needed to implement MoCRA.
PFAS, or ‘forever chemicals’
Some of the requested FDA funding is intended to prepare the agency to assess the use of per-and polyfluoroalkyl substances (PFAS) in cosmetics.
MoCRA sets a 3-year deadline for the FDA to issue an assessment of the use and potential risks of PFAS in cosmetics products. PFAS are sometimes added as ingredients in some cosmetic products, including lotions, cleansers, nail polish, shaving cream, foundation, lipstick, eyeliner, eyeshadow, and mascara, according to the FDA. Sometimes the presence of PFAS in cosmetics is unintentional and is the result of impurities in raw materials or is due to the breakdown of ingredients, the FDA said.
The FDA’s website says that so far, the available research doesn’t allow for “definitive conclusions about the potential health risks of PFAS in cosmetics.”
The Centers for Disease Control and Prevention has stated that research has suggested potential links between high levels of certain PFAS, in general, with increased cholesterol levels, changes in liver enzyme levels, increased risk of hypertension or preeclampsia in pregnant women, and increased risk of kidney or testicular cancer.
PFAS compounds often are used to resist grease, oil, water, and heat in industrial settings. They are used in thousands of products, from nonstick cookware to firefighting foams and protective gear, because they can reduce friction, according to a National Academies of Sciences, Engineering, and Medicine report on PFAS that was issued last year.
PFAS are known as “forever chemicals” because they contain a carbon-fluorine bond, which does not break naturally. Even when PFAS are transformed in the body, they can assume other forms of PFAS that preserve the troublesome carbon-fluorine bond. With PFAS, the human body is confronted with a substance it doesn’t have the tools to process.
This is in contrast to proteins and carbohydrates, which are in a sense prepackaged for relatively easy disassembly in the human body. Many of these compounds have weak links that enzymes and stomach acid can take apart, such as sulfur-to-sulfur (disulfide) bonds. That’s why protein-based biotech drugs are injected instead of administered as pills. The ultimate goal of this digestion is for the body to gain energy from these compounds.
But with PFAS, the body faces the challenge of carbon-fluorine bonds that are very hard to break down, and there is no payoff for these efforts, Graham F. Peaslee, PhD, professor of physics at the University of Notre Dame (Indiana), told this news organization.
“Nothing will naturally eat it because when you break the bond, it’s like eating celery,” he said. “You use more calories to eat the celery than you gain back from it.”
Interest from a U.S. senator
Dr. Peaslee was one of the authors of a 2021 article about PFAS in cosmetics that appeared in the journal Environmental Science and Technology Letters.
In the article, Dr. Peaslee and colleagues reported on their screening of 231 cosmetic products purchased in the United States and Canada using particle-induced gamma-ray emission spectroscopy. They found cases of undisclosed PFAS in cosmetic products. Foundations, mascaras, and lip products were noted as being especially problematic.
Sen. Susan Collins (R-ME) cited Dr. Peaslee’s article in a 2021 floor speech as she argued for having the FDA ban the intentional addition of PFAS to cosmetics.
“The findings of this study are particularly alarming, as many of these products are subject to direct human exposure,” Sen. Collins said. “For example, lipstick is often inadvertently ingested, and mascara is sometimes absorbed through tear ducts.”
In addition, workers at cosmetics plants may be exposed to PFAS and discarded cosmetics that have these compounds, which could potentially contaminate drinking water, Sen. Collins said. In 2021, she introduced legislation seeking a ban on PFAS that are intentionally added to cosmetics. That legislation did not advance through the Senate.
But the Senate Appropriations Committee, on which Sen. Collins is the ranking Republican, wants the FDA to keep a ban on PFAS in mind.
The Senate Agriculture Appropriations subcommittee, which oversees the FDA’s budget, raised the issue of PFAS and cosmetics in a June report. The FDA should develop a plan outlining research needed to inform “regulatory decision making, including potential development of a proposed rule to ban intentionally added PFAS substances in cosmetics,” the subcommittee said.
A version of this article first appeared on Medscape.com.
No link between most cancers and depression/anxiety: Study
from a large, individual participant data meta-analysis.
An exception was for lung and smoking-related cancers, but key covariates appeared to explain the relationship between depression, anxiety, and these cancer types, the investigators reported.
The findings challenge a common theory that depression and anxiety increase cancer risk and should “change current thinking,” they argue.
“Our results may come as a relief to many patients with cancer who believe their diagnosis is attributed to previous anxiety or depression,” first author Lonneke A. van Tuijl, PhD, of the University of Groningen and Utrecht University, the Netherlands, noted in a press release.
Analyses included data from up to nearly 320,000 individuals from the 18 prospective cohorts included in the international Psychosocial Factors and Cancer Incidence (PSY-CA) consortium. The cohorts are from studies conducted in the Netherlands, United Kingdom, Norway, and Canada, and included 25,803 patients with cancer. During follow-up of up to 26 years and more than 3.2 million person-years, depression and anxiety symptoms and diagnoses showed no association with overall breast, prostate, colorectal, and alcohol-related cancers (hazard ratios, 0.98-1.05).
For the specific cancer types, the investigators “found no evidence for an association between depression or anxiety and the incidence of colorectal cancer (HRs, 0.88-1.13), prostate cancer (HRs, 0.97-1.17), or alcohol-related cancers (HRs, 0.97-1.06).”
“For breast cancer, all pooled HRs were consistently negative but mean pooled HRs were close to 1 (HRs, 0.92-0.98) and the upper limit of the 95% confidence intervals all exceeded 1 (with the exception of anxiety symptoms),” they noted.
An increase in risk observed between depression and anxiety symptoms and diagnoses and lung cancer (HRs, 1.12-1.60) and smoking-related cancers (HRs, 1.06-1.60), in minimally adjusted models, was substantially attenuated after adjusting for known risk factors such as smoking, alcohol use, and body mass index (HRs, 1.04-1.08), the investigators reported.
The findings were published online in Cancer.
“Depression and anxiety have long been hypothesized to increase the risk for cancer. It is thought that the increased cancer risk can occur via several pathways, including health behaviors, or by influencing mutation, viral oncogenes, cell proliferation, or DNA repair,” the authors explained, noting that “[c]onclusions drawn in meta-analyses vary greatly, with some supporting an association between depression, anxiety, and cancer incidence and others finding no or a negligible association.”
The current findings “may help health professionals to alleviate feelings of guilt and self-blame in patients with cancer who attribute their diagnosis to previous depression or anxiety,” they said, noting that the findings “also underscore the importance of addressing tobacco smoking and other unhealthy behaviors – including those that may develop as a result of anxiety or depression.”
“However, further research is needed to understand exactly how depression, anxiety, health behaviors, and lung cancer are related,” said Dr. Tuijl.
Dr. Tuijl has received grants and travel support from the Dutch Cancer Society (KWF).
from a large, individual participant data meta-analysis.
An exception was for lung and smoking-related cancers, but key covariates appeared to explain the relationship between depression, anxiety, and these cancer types, the investigators reported.
The findings challenge a common theory that depression and anxiety increase cancer risk and should “change current thinking,” they argue.
“Our results may come as a relief to many patients with cancer who believe their diagnosis is attributed to previous anxiety or depression,” first author Lonneke A. van Tuijl, PhD, of the University of Groningen and Utrecht University, the Netherlands, noted in a press release.
Analyses included data from up to nearly 320,000 individuals from the 18 prospective cohorts included in the international Psychosocial Factors and Cancer Incidence (PSY-CA) consortium. The cohorts are from studies conducted in the Netherlands, United Kingdom, Norway, and Canada, and included 25,803 patients with cancer. During follow-up of up to 26 years and more than 3.2 million person-years, depression and anxiety symptoms and diagnoses showed no association with overall breast, prostate, colorectal, and alcohol-related cancers (hazard ratios, 0.98-1.05).
For the specific cancer types, the investigators “found no evidence for an association between depression or anxiety and the incidence of colorectal cancer (HRs, 0.88-1.13), prostate cancer (HRs, 0.97-1.17), or alcohol-related cancers (HRs, 0.97-1.06).”
“For breast cancer, all pooled HRs were consistently negative but mean pooled HRs were close to 1 (HRs, 0.92-0.98) and the upper limit of the 95% confidence intervals all exceeded 1 (with the exception of anxiety symptoms),” they noted.
An increase in risk observed between depression and anxiety symptoms and diagnoses and lung cancer (HRs, 1.12-1.60) and smoking-related cancers (HRs, 1.06-1.60), in minimally adjusted models, was substantially attenuated after adjusting for known risk factors such as smoking, alcohol use, and body mass index (HRs, 1.04-1.08), the investigators reported.
The findings were published online in Cancer.
“Depression and anxiety have long been hypothesized to increase the risk for cancer. It is thought that the increased cancer risk can occur via several pathways, including health behaviors, or by influencing mutation, viral oncogenes, cell proliferation, or DNA repair,” the authors explained, noting that “[c]onclusions drawn in meta-analyses vary greatly, with some supporting an association between depression, anxiety, and cancer incidence and others finding no or a negligible association.”
The current findings “may help health professionals to alleviate feelings of guilt and self-blame in patients with cancer who attribute their diagnosis to previous depression or anxiety,” they said, noting that the findings “also underscore the importance of addressing tobacco smoking and other unhealthy behaviors – including those that may develop as a result of anxiety or depression.”
“However, further research is needed to understand exactly how depression, anxiety, health behaviors, and lung cancer are related,” said Dr. Tuijl.
Dr. Tuijl has received grants and travel support from the Dutch Cancer Society (KWF).
from a large, individual participant data meta-analysis.
An exception was for lung and smoking-related cancers, but key covariates appeared to explain the relationship between depression, anxiety, and these cancer types, the investigators reported.
The findings challenge a common theory that depression and anxiety increase cancer risk and should “change current thinking,” they argue.
“Our results may come as a relief to many patients with cancer who believe their diagnosis is attributed to previous anxiety or depression,” first author Lonneke A. van Tuijl, PhD, of the University of Groningen and Utrecht University, the Netherlands, noted in a press release.
Analyses included data from up to nearly 320,000 individuals from the 18 prospective cohorts included in the international Psychosocial Factors and Cancer Incidence (PSY-CA) consortium. The cohorts are from studies conducted in the Netherlands, United Kingdom, Norway, and Canada, and included 25,803 patients with cancer. During follow-up of up to 26 years and more than 3.2 million person-years, depression and anxiety symptoms and diagnoses showed no association with overall breast, prostate, colorectal, and alcohol-related cancers (hazard ratios, 0.98-1.05).
For the specific cancer types, the investigators “found no evidence for an association between depression or anxiety and the incidence of colorectal cancer (HRs, 0.88-1.13), prostate cancer (HRs, 0.97-1.17), or alcohol-related cancers (HRs, 0.97-1.06).”
“For breast cancer, all pooled HRs were consistently negative but mean pooled HRs were close to 1 (HRs, 0.92-0.98) and the upper limit of the 95% confidence intervals all exceeded 1 (with the exception of anxiety symptoms),” they noted.
An increase in risk observed between depression and anxiety symptoms and diagnoses and lung cancer (HRs, 1.12-1.60) and smoking-related cancers (HRs, 1.06-1.60), in minimally adjusted models, was substantially attenuated after adjusting for known risk factors such as smoking, alcohol use, and body mass index (HRs, 1.04-1.08), the investigators reported.
The findings were published online in Cancer.
“Depression and anxiety have long been hypothesized to increase the risk for cancer. It is thought that the increased cancer risk can occur via several pathways, including health behaviors, or by influencing mutation, viral oncogenes, cell proliferation, or DNA repair,” the authors explained, noting that “[c]onclusions drawn in meta-analyses vary greatly, with some supporting an association between depression, anxiety, and cancer incidence and others finding no or a negligible association.”
The current findings “may help health professionals to alleviate feelings of guilt and self-blame in patients with cancer who attribute their diagnosis to previous depression or anxiety,” they said, noting that the findings “also underscore the importance of addressing tobacco smoking and other unhealthy behaviors – including those that may develop as a result of anxiety or depression.”
“However, further research is needed to understand exactly how depression, anxiety, health behaviors, and lung cancer are related,” said Dr. Tuijl.
Dr. Tuijl has received grants and travel support from the Dutch Cancer Society (KWF).
FROM CANCER
Cruel summer for medical students and Taylor Swift fans
Most medical students won’t see Taylor Swift perform her hit song “Cruel Summer,” but they will spend thousands of dollars on ERAS as they prepare for the 2024 residency match. Medical students applying for residency tend to be as stressed out as Swifties trying to score concert tickets. Aside from the expenses of residency applications, students also face an increasingly complex application process: a match algorithm many of them do not understand and major changes to the application process that most learn about right before the application cycle begins.
I have gone through two matches myself, one for internal medicine and one for neurology, and I have also guided students through the process for almost a decade as a dean of student affairs at a medical school. Every summer, the application process is filled with numerous changes, often with little, if any, warning for the students. One year, for example, a specialty required additional essays tailored to each program. Though this requirement may have helped programs discern which students are most enthusiastic about their programs, it also disadvantaged students working on busier rotations, strapped for time to write as many as 70 additional essays in a matter of weeks.
Other recent changes have included “signaling” programs, selecting preferred regions, and preinterview recordings for some specialties. In 2023, students cannot include more than 10 activities on their ERAS application. I have spoken to students at numerous medical schools concerned about the difficulty of selecting 10 activities out of dozens of meaningful pursuits throughout their journeys; this challenge is particularly acute for students who had other careers before entering medical school.
The stress continues to mount even after residency applications have been submitted. Students often feel tied to their phones because offers for residency interviews roll in day and night by email, and if they wait more than a few hours to respond, they’re often moved to a waiting list for their preferred interview date. One year, while we were rounding on patients, a student stepped away to schedule an interview; while doing so, he missed out on managing a patient who developed a neurologic emergency. Thankfully, many but not all specialties have put rules in place to allow students more time to think through interview offers. Having more time to think, even if it’s just 48 hours, may decrease stress, limit the negative impacts on medical education, and promote informed decisions during interview season.
To be sure, most changes are being made in an effort to improve the experience of the students and programs. But as with anything, the result has been a mix of good and bad. The transition to virtual interviews allowed students to apply more broadly to programs without worrying about travel costs. The move also benefits students with disabilities who face accessibility and other challenges with traveling. However, virtual interviews came with several downsides, including but not limited to an increased number of applications submitted (recall that this was also a benefit), interview hoarding, and challenges of connecting personally via virtual platform. Despite the virtual format, applicants increasingly are doing in-person second looks, which some worry may give those applicants an additional advantage over applicants who do not have the time or financial resources to travel for a second look. Despite these shortcomings, it is important that virtual interviews remain an option for those applicants who need it.
Another change, which has been extensively debated in medical education in recent years, was the switch to pass/fail on the USMLE Step 1 exam. Though this move decreased the stress students experienced in the first 2 years of medical school, it has resulted in a new challenge as many residency programs put more emphasis on USMLE Step 2. Many medical students feel they do not have a good gauge of their competitiveness until a few weeks before they submit their application, particularly those applicants attending medical schools that do not provide them with information regarding their class standing until right before they submit their applications.
By the time Swift’s Eras Tour ends in the summer of 2024, medical students will already have matched and started their residency programs. At the same time, a new batch of students will be entering the next year’s match. Though the number of anticipated changes may not reach the level of seismic activity caused by the Swifties at her Seattle concert, many medical students fear that the changes may be just like tectonic plates shifting the match process away from its original purpose: to provide an orderly and fair mechanism for matching the preferences of applicants for U.S. residency positions with the preferences of residency program directors.
Dr. Etienne is with WMCHealth Good Samaritan Hospital, New York, and New York Medical College. He disclosed no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Most medical students won’t see Taylor Swift perform her hit song “Cruel Summer,” but they will spend thousands of dollars on ERAS as they prepare for the 2024 residency match. Medical students applying for residency tend to be as stressed out as Swifties trying to score concert tickets. Aside from the expenses of residency applications, students also face an increasingly complex application process: a match algorithm many of them do not understand and major changes to the application process that most learn about right before the application cycle begins.
I have gone through two matches myself, one for internal medicine and one for neurology, and I have also guided students through the process for almost a decade as a dean of student affairs at a medical school. Every summer, the application process is filled with numerous changes, often with little, if any, warning for the students. One year, for example, a specialty required additional essays tailored to each program. Though this requirement may have helped programs discern which students are most enthusiastic about their programs, it also disadvantaged students working on busier rotations, strapped for time to write as many as 70 additional essays in a matter of weeks.
Other recent changes have included “signaling” programs, selecting preferred regions, and preinterview recordings for some specialties. In 2023, students cannot include more than 10 activities on their ERAS application. I have spoken to students at numerous medical schools concerned about the difficulty of selecting 10 activities out of dozens of meaningful pursuits throughout their journeys; this challenge is particularly acute for students who had other careers before entering medical school.
The stress continues to mount even after residency applications have been submitted. Students often feel tied to their phones because offers for residency interviews roll in day and night by email, and if they wait more than a few hours to respond, they’re often moved to a waiting list for their preferred interview date. One year, while we were rounding on patients, a student stepped away to schedule an interview; while doing so, he missed out on managing a patient who developed a neurologic emergency. Thankfully, many but not all specialties have put rules in place to allow students more time to think through interview offers. Having more time to think, even if it’s just 48 hours, may decrease stress, limit the negative impacts on medical education, and promote informed decisions during interview season.
To be sure, most changes are being made in an effort to improve the experience of the students and programs. But as with anything, the result has been a mix of good and bad. The transition to virtual interviews allowed students to apply more broadly to programs without worrying about travel costs. The move also benefits students with disabilities who face accessibility and other challenges with traveling. However, virtual interviews came with several downsides, including but not limited to an increased number of applications submitted (recall that this was also a benefit), interview hoarding, and challenges of connecting personally via virtual platform. Despite the virtual format, applicants increasingly are doing in-person second looks, which some worry may give those applicants an additional advantage over applicants who do not have the time or financial resources to travel for a second look. Despite these shortcomings, it is important that virtual interviews remain an option for those applicants who need it.
Another change, which has been extensively debated in medical education in recent years, was the switch to pass/fail on the USMLE Step 1 exam. Though this move decreased the stress students experienced in the first 2 years of medical school, it has resulted in a new challenge as many residency programs put more emphasis on USMLE Step 2. Many medical students feel they do not have a good gauge of their competitiveness until a few weeks before they submit their application, particularly those applicants attending medical schools that do not provide them with information regarding their class standing until right before they submit their applications.
By the time Swift’s Eras Tour ends in the summer of 2024, medical students will already have matched and started their residency programs. At the same time, a new batch of students will be entering the next year’s match. Though the number of anticipated changes may not reach the level of seismic activity caused by the Swifties at her Seattle concert, many medical students fear that the changes may be just like tectonic plates shifting the match process away from its original purpose: to provide an orderly and fair mechanism for matching the preferences of applicants for U.S. residency positions with the preferences of residency program directors.
Dr. Etienne is with WMCHealth Good Samaritan Hospital, New York, and New York Medical College. He disclosed no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Most medical students won’t see Taylor Swift perform her hit song “Cruel Summer,” but they will spend thousands of dollars on ERAS as they prepare for the 2024 residency match. Medical students applying for residency tend to be as stressed out as Swifties trying to score concert tickets. Aside from the expenses of residency applications, students also face an increasingly complex application process: a match algorithm many of them do not understand and major changes to the application process that most learn about right before the application cycle begins.
I have gone through two matches myself, one for internal medicine and one for neurology, and I have also guided students through the process for almost a decade as a dean of student affairs at a medical school. Every summer, the application process is filled with numerous changes, often with little, if any, warning for the students. One year, for example, a specialty required additional essays tailored to each program. Though this requirement may have helped programs discern which students are most enthusiastic about their programs, it also disadvantaged students working on busier rotations, strapped for time to write as many as 70 additional essays in a matter of weeks.
Other recent changes have included “signaling” programs, selecting preferred regions, and preinterview recordings for some specialties. In 2023, students cannot include more than 10 activities on their ERAS application. I have spoken to students at numerous medical schools concerned about the difficulty of selecting 10 activities out of dozens of meaningful pursuits throughout their journeys; this challenge is particularly acute for students who had other careers before entering medical school.
The stress continues to mount even after residency applications have been submitted. Students often feel tied to their phones because offers for residency interviews roll in day and night by email, and if they wait more than a few hours to respond, they’re often moved to a waiting list for their preferred interview date. One year, while we were rounding on patients, a student stepped away to schedule an interview; while doing so, he missed out on managing a patient who developed a neurologic emergency. Thankfully, many but not all specialties have put rules in place to allow students more time to think through interview offers. Having more time to think, even if it’s just 48 hours, may decrease stress, limit the negative impacts on medical education, and promote informed decisions during interview season.
To be sure, most changes are being made in an effort to improve the experience of the students and programs. But as with anything, the result has been a mix of good and bad. The transition to virtual interviews allowed students to apply more broadly to programs without worrying about travel costs. The move also benefits students with disabilities who face accessibility and other challenges with traveling. However, virtual interviews came with several downsides, including but not limited to an increased number of applications submitted (recall that this was also a benefit), interview hoarding, and challenges of connecting personally via virtual platform. Despite the virtual format, applicants increasingly are doing in-person second looks, which some worry may give those applicants an additional advantage over applicants who do not have the time or financial resources to travel for a second look. Despite these shortcomings, it is important that virtual interviews remain an option for those applicants who need it.
Another change, which has been extensively debated in medical education in recent years, was the switch to pass/fail on the USMLE Step 1 exam. Though this move decreased the stress students experienced in the first 2 years of medical school, it has resulted in a new challenge as many residency programs put more emphasis on USMLE Step 2. Many medical students feel they do not have a good gauge of their competitiveness until a few weeks before they submit their application, particularly those applicants attending medical schools that do not provide them with information regarding their class standing until right before they submit their applications.
By the time Swift’s Eras Tour ends in the summer of 2024, medical students will already have matched and started their residency programs. At the same time, a new batch of students will be entering the next year’s match. Though the number of anticipated changes may not reach the level of seismic activity caused by the Swifties at her Seattle concert, many medical students fear that the changes may be just like tectonic plates shifting the match process away from its original purpose: to provide an orderly and fair mechanism for matching the preferences of applicants for U.S. residency positions with the preferences of residency program directors.
Dr. Etienne is with WMCHealth Good Samaritan Hospital, New York, and New York Medical College. He disclosed no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
ESC issues new guidelines on infective endocarditis
(IE) – a rare and potentially lethal infection of the heart’s lining and valves.
The document revises the 2015 version, based on advances in imaging and a trial of antibiotic prophylaxis, among other new developments.
Cochairpersons of the writing task force, Victoria Delgado, MD, PhD, and Michael A. Borger, MD, PhD, and other members presented and discussed the guidelines in three packed sessions at the annual congress of the European Society of Cardiology, and the document was simultaneously published online in the European Heart Journal.
Endocarditis “can present with so many different clinical scenarios, so making the diagnosis can be very challenging,” Dr. Borger, from the Heart Center of Leipzig, Germany, said in an interview.
Diagnosing a lethal, rare, but not uncommon disease such as endocarditis “is something that clinicians struggle with every day,” he noted, pointing to the large overflowing auditoriums where these guidelines were presented. Dr. Borger identified four main takeaways from the document:
- Increased level of recommendation and a clearer definition of prevention and prophylaxis of endocarditis in higher-risk patients.
- An increasing role of nonechocardiographic, advanced cardiac imaging techniques in the diagnosis of endocarditis. “The advanced cardiac imaging techniques achieved the same level of recommendation as echocardiography,” he noted.
- More precisely defined indications for surgery and the timing for surgery, as well as a couple of new surgical recommendations.
- More precisely defined criteria for diagnosing and managing cardiac electronic implantable device (CIED)–associated endocarditis.
The guidelines identify patients at high risk for IE as those with previous IE and patients with surgically implanted prosthetic valves, certain congenital heart diseases, surgery with prosthetic material, or a ventricular assist device as destination therapy and recommend giving them prophylactic antibiotics before oral or dental procedures.
Patients at intermediate risk for IE include those with rheumatic heart disease, nonrheumatic degenerative valve disease, congenital valve abnormalities, CIEDs, and hypertrophic cardiomyopathy. They should be evaluated on a case-by-case basis for this prophylaxis, the guideline authors write.
Making the diagnosis
Advances in imaging techniques necessitated a revised version of the endocarditis guidelines, Dr. Borger noted.
Patients are classified as having a definite, possible, or rejected diagnosis of IE (where a definite diagnosis requires two major criteria, or one major criterion and at least three minor criteria, or five minor criteria).
The two major criteria are blood cultures positive for IE and imaging positive for IE by transesophageal echocardiography, transthoracic echocardiography, or – what is new – cardiac computed tomography, 18F-fluorodeoxyglucose positron emission tomography, or white blood cell single photon emission tomography/CT.
The five minor criteria are predisposing conditions, fever (temperature > 38° C), embolic vascular dissemination, immunologic phenomena, and microbiological evidence.
Patient education
Patient education is “paramount to early diagnosis and treatment,” Dr. Delgado, from Germans Trias i Pujol Hospital, Barcelona, said in a press release from ESC. “Those with valvular heart disease or previous heart valve surgery should be particularly diligent with regards to prevention and recognizing symptoms.”
IE occurs when bacteria or fungi enter the bloodstream, for example through skin infections, dental procedures, and surgery. Symptoms include fever, night sweats, unexplained weight loss, cough, dizziness, and fainting, the press release notes.
“We have several clinical scenarios that are increasing,” Dr. Delgado said at an Ask the Experts session, including implanted cardiac electronic devices, new transcatheter therapies, and increasing endocarditis in people who use injection drugs, “and we have recommendation of evaluation of these patients at follow up.”
“The guidelines have 34 new recommendations,” she noted in a Guideline Overview session. She drew attention to a central figure, “where we tried to summarize the pathway of the patient who is diagnosed with endocarditis, and where we highlight the role of the endocarditis team,” she said.
The guidelines specify a prophylactic antibiotic regimen for high-risk dental procedures, for children and for adults with or without allergy to penicillin or ampicillin, given as a single dose 30-60 minutes before a procedure, she noted.
A new recommendation is that systemic antibiotic prophylaxis may be considered for high-risk patients undergoing invasive procedures of the respiratory, gastrointestinal, or genitourinary tract; skin; or musculoskeletal system.
“It is very important to have a well-educated population,” Dr. Delgado stressed.
Figure 2 of the guideline depicts what patients should do, she said, such as “maintain good dental hygiene, avoid tattoos and piercings, be mindful of infections, do not self-prescribe antibiotics.” This card can be given to the patient, and they can show it to doctors before interventions.
The main targets for antibiotic prophylaxis are oral streptococci, but the emerging and increasing resistance of these bacteria are reasons why patients should not self-prescribe, Dr. Delgado noted.
“Patients should not be self-medicating in order to try to lower their risk of endocarditis,” Dr. Borger said. “They should be speaking to their physicians and have their physician group them according to their risk category.”
“If they are low risk, there’s no reason to take antibiotic prophylaxis [before oral or dental procedures], but if they are high risk, they should not only be taking antibiotic prophylaxis, they should also be doing things like good dental hygiene – visiting the dentist once or twice a year, avoiding unnecessary procedures such as tattooing and piercings, and quick aseptic management of skin wounds.”
POET Trial: Earlier shift to oral antibiotics at home
“Another very important point is the increasing use of oral outpatient antibiotic therapy based on the Partial Oral Treatment of Endocarditis (POET) randomized trial,” Dr. Borger observed. “That’s a new recommendation,” he said, “with significant implications for the care of patients with this oftentimes life-threatening disease.”
In POET, patients in stable condition who had endocarditis on the left side of the heart caused by streptococci, Enterococcus faecalis, Staphylococcus aureus, or coagulase-negative staphylococci were randomly assigned to continue treatment with intravenous antibiotics (199 patients) or to shift to step-down treatment with oral antibiotics (201 patients) after at least 10 days of initial treatment with IV antibiotics.
The 5-year results were published in 2019 in the New England Journal of Medicine and presented at ESC that year. “We were hoping or expecting to see that oral outpatient therapy would be equivalent to inpatient IV therapy,” Dr. Borger said, “but we were surprised to see that oral outpatient therapy was actually statistically significantly better in terms of survival, a very hard outcome, at 5 years after the randomization.”
“This was an important part of our new guideline document. In select patients who are ‘clinically stable’,” as defined in the guidelines, he said, “they could be successfully managed at home with oral antibiotics, rather than keeping them in hospital the whole 6 weeks.”
“In the U.S. and in Canada, a lot of patients are sent home for intravenous therapy, whereas that practice doesn’t exist in a lot of places in Europe. The patients are sitting in the hospital here for 6 weeks, oftentimes for no other reason – just to get their IV antibiotic therapy. The POET trial has shown us that that is probably the wrong thing to be doing.”
Earlier surgical intervention
The new guidelines also recommend that “once there is an indication to do cardiac surgery, it should be promptly performed,” Dr. Borger noted.
Surgery to remove infected material and drain abscesses is indicated for patients with heart failure or uncontrolled infection and to prevent embolism.
“We have defined emergency indications that should be done within 24 hours; urgent, which should be done within 3-5 days; and nonurgent, more than 5 days but within the same hospitalization,” he elaborated. “We’re basically trying to encourage surgeons and nonsurgeons that once there is an indication for surgery, there’s not a lot of benefit to just waiting. You should proceed with operation in a timely manner” to improve survival.
The guidelines recommend surgery for early prosthetic valve endocarditis, within 6 months of valve surgery, with new valve replacement and complete debridement.
Patients who present with stroke and require surgery are not uncommon, Dr. Borger noted. Ischemic stroke should not be a reason to delay surgery, and patients with hemorrhagic stoke, with favorable features, can undergo surgery.
The guidelines provide a figure for the management of CIED-related infective endocarditis. They also include a new section devoted to patient-centered care and shared decision-making.
The guidelines were endorsed by the European Association for Cardio-Thoracic Surgery and the European Association of Nuclear Medicine. The writing task force included representatives from EACTS, EANM, and the European Society of Clinical Microbiology and Infectious Diseases.
The complete guidelines, as well as pocket guidelines, essential messages, a pocket guidelines app, and an official guidelines slide set, all addressing endocarditis, are available from the ESC website.
The guidelines did not receive any funding. The disclosure forms of all experts involved in their development are available on the ESC website.
A version of this article appeared on Medscape.com.
(IE) – a rare and potentially lethal infection of the heart’s lining and valves.
The document revises the 2015 version, based on advances in imaging and a trial of antibiotic prophylaxis, among other new developments.
Cochairpersons of the writing task force, Victoria Delgado, MD, PhD, and Michael A. Borger, MD, PhD, and other members presented and discussed the guidelines in three packed sessions at the annual congress of the European Society of Cardiology, and the document was simultaneously published online in the European Heart Journal.
Endocarditis “can present with so many different clinical scenarios, so making the diagnosis can be very challenging,” Dr. Borger, from the Heart Center of Leipzig, Germany, said in an interview.
Diagnosing a lethal, rare, but not uncommon disease such as endocarditis “is something that clinicians struggle with every day,” he noted, pointing to the large overflowing auditoriums where these guidelines were presented. Dr. Borger identified four main takeaways from the document:
- Increased level of recommendation and a clearer definition of prevention and prophylaxis of endocarditis in higher-risk patients.
- An increasing role of nonechocardiographic, advanced cardiac imaging techniques in the diagnosis of endocarditis. “The advanced cardiac imaging techniques achieved the same level of recommendation as echocardiography,” he noted.
- More precisely defined indications for surgery and the timing for surgery, as well as a couple of new surgical recommendations.
- More precisely defined criteria for diagnosing and managing cardiac electronic implantable device (CIED)–associated endocarditis.
The guidelines identify patients at high risk for IE as those with previous IE and patients with surgically implanted prosthetic valves, certain congenital heart diseases, surgery with prosthetic material, or a ventricular assist device as destination therapy and recommend giving them prophylactic antibiotics before oral or dental procedures.
Patients at intermediate risk for IE include those with rheumatic heart disease, nonrheumatic degenerative valve disease, congenital valve abnormalities, CIEDs, and hypertrophic cardiomyopathy. They should be evaluated on a case-by-case basis for this prophylaxis, the guideline authors write.
Making the diagnosis
Advances in imaging techniques necessitated a revised version of the endocarditis guidelines, Dr. Borger noted.
Patients are classified as having a definite, possible, or rejected diagnosis of IE (where a definite diagnosis requires two major criteria, or one major criterion and at least three minor criteria, or five minor criteria).
The two major criteria are blood cultures positive for IE and imaging positive for IE by transesophageal echocardiography, transthoracic echocardiography, or – what is new – cardiac computed tomography, 18F-fluorodeoxyglucose positron emission tomography, or white blood cell single photon emission tomography/CT.
The five minor criteria are predisposing conditions, fever (temperature > 38° C), embolic vascular dissemination, immunologic phenomena, and microbiological evidence.
Patient education
Patient education is “paramount to early diagnosis and treatment,” Dr. Delgado, from Germans Trias i Pujol Hospital, Barcelona, said in a press release from ESC. “Those with valvular heart disease or previous heart valve surgery should be particularly diligent with regards to prevention and recognizing symptoms.”
IE occurs when bacteria or fungi enter the bloodstream, for example through skin infections, dental procedures, and surgery. Symptoms include fever, night sweats, unexplained weight loss, cough, dizziness, and fainting, the press release notes.
“We have several clinical scenarios that are increasing,” Dr. Delgado said at an Ask the Experts session, including implanted cardiac electronic devices, new transcatheter therapies, and increasing endocarditis in people who use injection drugs, “and we have recommendation of evaluation of these patients at follow up.”
“The guidelines have 34 new recommendations,” she noted in a Guideline Overview session. She drew attention to a central figure, “where we tried to summarize the pathway of the patient who is diagnosed with endocarditis, and where we highlight the role of the endocarditis team,” she said.
The guidelines specify a prophylactic antibiotic regimen for high-risk dental procedures, for children and for adults with or without allergy to penicillin or ampicillin, given as a single dose 30-60 minutes before a procedure, she noted.
A new recommendation is that systemic antibiotic prophylaxis may be considered for high-risk patients undergoing invasive procedures of the respiratory, gastrointestinal, or genitourinary tract; skin; or musculoskeletal system.
“It is very important to have a well-educated population,” Dr. Delgado stressed.
Figure 2 of the guideline depicts what patients should do, she said, such as “maintain good dental hygiene, avoid tattoos and piercings, be mindful of infections, do not self-prescribe antibiotics.” This card can be given to the patient, and they can show it to doctors before interventions.
The main targets for antibiotic prophylaxis are oral streptococci, but the emerging and increasing resistance of these bacteria are reasons why patients should not self-prescribe, Dr. Delgado noted.
“Patients should not be self-medicating in order to try to lower their risk of endocarditis,” Dr. Borger said. “They should be speaking to their physicians and have their physician group them according to their risk category.”
“If they are low risk, there’s no reason to take antibiotic prophylaxis [before oral or dental procedures], but if they are high risk, they should not only be taking antibiotic prophylaxis, they should also be doing things like good dental hygiene – visiting the dentist once or twice a year, avoiding unnecessary procedures such as tattooing and piercings, and quick aseptic management of skin wounds.”
POET Trial: Earlier shift to oral antibiotics at home
“Another very important point is the increasing use of oral outpatient antibiotic therapy based on the Partial Oral Treatment of Endocarditis (POET) randomized trial,” Dr. Borger observed. “That’s a new recommendation,” he said, “with significant implications for the care of patients with this oftentimes life-threatening disease.”
In POET, patients in stable condition who had endocarditis on the left side of the heart caused by streptococci, Enterococcus faecalis, Staphylococcus aureus, or coagulase-negative staphylococci were randomly assigned to continue treatment with intravenous antibiotics (199 patients) or to shift to step-down treatment with oral antibiotics (201 patients) after at least 10 days of initial treatment with IV antibiotics.
The 5-year results were published in 2019 in the New England Journal of Medicine and presented at ESC that year. “We were hoping or expecting to see that oral outpatient therapy would be equivalent to inpatient IV therapy,” Dr. Borger said, “but we were surprised to see that oral outpatient therapy was actually statistically significantly better in terms of survival, a very hard outcome, at 5 years after the randomization.”
“This was an important part of our new guideline document. In select patients who are ‘clinically stable’,” as defined in the guidelines, he said, “they could be successfully managed at home with oral antibiotics, rather than keeping them in hospital the whole 6 weeks.”
“In the U.S. and in Canada, a lot of patients are sent home for intravenous therapy, whereas that practice doesn’t exist in a lot of places in Europe. The patients are sitting in the hospital here for 6 weeks, oftentimes for no other reason – just to get their IV antibiotic therapy. The POET trial has shown us that that is probably the wrong thing to be doing.”
Earlier surgical intervention
The new guidelines also recommend that “once there is an indication to do cardiac surgery, it should be promptly performed,” Dr. Borger noted.
Surgery to remove infected material and drain abscesses is indicated for patients with heart failure or uncontrolled infection and to prevent embolism.
“We have defined emergency indications that should be done within 24 hours; urgent, which should be done within 3-5 days; and nonurgent, more than 5 days but within the same hospitalization,” he elaborated. “We’re basically trying to encourage surgeons and nonsurgeons that once there is an indication for surgery, there’s not a lot of benefit to just waiting. You should proceed with operation in a timely manner” to improve survival.
The guidelines recommend surgery for early prosthetic valve endocarditis, within 6 months of valve surgery, with new valve replacement and complete debridement.
Patients who present with stroke and require surgery are not uncommon, Dr. Borger noted. Ischemic stroke should not be a reason to delay surgery, and patients with hemorrhagic stoke, with favorable features, can undergo surgery.
The guidelines provide a figure for the management of CIED-related infective endocarditis. They also include a new section devoted to patient-centered care and shared decision-making.
The guidelines were endorsed by the European Association for Cardio-Thoracic Surgery and the European Association of Nuclear Medicine. The writing task force included representatives from EACTS, EANM, and the European Society of Clinical Microbiology and Infectious Diseases.
The complete guidelines, as well as pocket guidelines, essential messages, a pocket guidelines app, and an official guidelines slide set, all addressing endocarditis, are available from the ESC website.
The guidelines did not receive any funding. The disclosure forms of all experts involved in their development are available on the ESC website.
A version of this article appeared on Medscape.com.
(IE) – a rare and potentially lethal infection of the heart’s lining and valves.
The document revises the 2015 version, based on advances in imaging and a trial of antibiotic prophylaxis, among other new developments.
Cochairpersons of the writing task force, Victoria Delgado, MD, PhD, and Michael A. Borger, MD, PhD, and other members presented and discussed the guidelines in three packed sessions at the annual congress of the European Society of Cardiology, and the document was simultaneously published online in the European Heart Journal.
Endocarditis “can present with so many different clinical scenarios, so making the diagnosis can be very challenging,” Dr. Borger, from the Heart Center of Leipzig, Germany, said in an interview.
Diagnosing a lethal, rare, but not uncommon disease such as endocarditis “is something that clinicians struggle with every day,” he noted, pointing to the large overflowing auditoriums where these guidelines were presented. Dr. Borger identified four main takeaways from the document:
- Increased level of recommendation and a clearer definition of prevention and prophylaxis of endocarditis in higher-risk patients.
- An increasing role of nonechocardiographic, advanced cardiac imaging techniques in the diagnosis of endocarditis. “The advanced cardiac imaging techniques achieved the same level of recommendation as echocardiography,” he noted.
- More precisely defined indications for surgery and the timing for surgery, as well as a couple of new surgical recommendations.
- More precisely defined criteria for diagnosing and managing cardiac electronic implantable device (CIED)–associated endocarditis.
The guidelines identify patients at high risk for IE as those with previous IE and patients with surgically implanted prosthetic valves, certain congenital heart diseases, surgery with prosthetic material, or a ventricular assist device as destination therapy and recommend giving them prophylactic antibiotics before oral or dental procedures.
Patients at intermediate risk for IE include those with rheumatic heart disease, nonrheumatic degenerative valve disease, congenital valve abnormalities, CIEDs, and hypertrophic cardiomyopathy. They should be evaluated on a case-by-case basis for this prophylaxis, the guideline authors write.
Making the diagnosis
Advances in imaging techniques necessitated a revised version of the endocarditis guidelines, Dr. Borger noted.
Patients are classified as having a definite, possible, or rejected diagnosis of IE (where a definite diagnosis requires two major criteria, or one major criterion and at least three minor criteria, or five minor criteria).
The two major criteria are blood cultures positive for IE and imaging positive for IE by transesophageal echocardiography, transthoracic echocardiography, or – what is new – cardiac computed tomography, 18F-fluorodeoxyglucose positron emission tomography, or white blood cell single photon emission tomography/CT.
The five minor criteria are predisposing conditions, fever (temperature > 38° C), embolic vascular dissemination, immunologic phenomena, and microbiological evidence.
Patient education
Patient education is “paramount to early diagnosis and treatment,” Dr. Delgado, from Germans Trias i Pujol Hospital, Barcelona, said in a press release from ESC. “Those with valvular heart disease or previous heart valve surgery should be particularly diligent with regards to prevention and recognizing symptoms.”
IE occurs when bacteria or fungi enter the bloodstream, for example through skin infections, dental procedures, and surgery. Symptoms include fever, night sweats, unexplained weight loss, cough, dizziness, and fainting, the press release notes.
“We have several clinical scenarios that are increasing,” Dr. Delgado said at an Ask the Experts session, including implanted cardiac electronic devices, new transcatheter therapies, and increasing endocarditis in people who use injection drugs, “and we have recommendation of evaluation of these patients at follow up.”
“The guidelines have 34 new recommendations,” she noted in a Guideline Overview session. She drew attention to a central figure, “where we tried to summarize the pathway of the patient who is diagnosed with endocarditis, and where we highlight the role of the endocarditis team,” she said.
The guidelines specify a prophylactic antibiotic regimen for high-risk dental procedures, for children and for adults with or without allergy to penicillin or ampicillin, given as a single dose 30-60 minutes before a procedure, she noted.
A new recommendation is that systemic antibiotic prophylaxis may be considered for high-risk patients undergoing invasive procedures of the respiratory, gastrointestinal, or genitourinary tract; skin; or musculoskeletal system.
“It is very important to have a well-educated population,” Dr. Delgado stressed.
Figure 2 of the guideline depicts what patients should do, she said, such as “maintain good dental hygiene, avoid tattoos and piercings, be mindful of infections, do not self-prescribe antibiotics.” This card can be given to the patient, and they can show it to doctors before interventions.
The main targets for antibiotic prophylaxis are oral streptococci, but the emerging and increasing resistance of these bacteria are reasons why patients should not self-prescribe, Dr. Delgado noted.
“Patients should not be self-medicating in order to try to lower their risk of endocarditis,” Dr. Borger said. “They should be speaking to their physicians and have their physician group them according to their risk category.”
“If they are low risk, there’s no reason to take antibiotic prophylaxis [before oral or dental procedures], but if they are high risk, they should not only be taking antibiotic prophylaxis, they should also be doing things like good dental hygiene – visiting the dentist once or twice a year, avoiding unnecessary procedures such as tattooing and piercings, and quick aseptic management of skin wounds.”
POET Trial: Earlier shift to oral antibiotics at home
“Another very important point is the increasing use of oral outpatient antibiotic therapy based on the Partial Oral Treatment of Endocarditis (POET) randomized trial,” Dr. Borger observed. “That’s a new recommendation,” he said, “with significant implications for the care of patients with this oftentimes life-threatening disease.”
In POET, patients in stable condition who had endocarditis on the left side of the heart caused by streptococci, Enterococcus faecalis, Staphylococcus aureus, or coagulase-negative staphylococci were randomly assigned to continue treatment with intravenous antibiotics (199 patients) or to shift to step-down treatment with oral antibiotics (201 patients) after at least 10 days of initial treatment with IV antibiotics.
The 5-year results were published in 2019 in the New England Journal of Medicine and presented at ESC that year. “We were hoping or expecting to see that oral outpatient therapy would be equivalent to inpatient IV therapy,” Dr. Borger said, “but we were surprised to see that oral outpatient therapy was actually statistically significantly better in terms of survival, a very hard outcome, at 5 years after the randomization.”
“This was an important part of our new guideline document. In select patients who are ‘clinically stable’,” as defined in the guidelines, he said, “they could be successfully managed at home with oral antibiotics, rather than keeping them in hospital the whole 6 weeks.”
“In the U.S. and in Canada, a lot of patients are sent home for intravenous therapy, whereas that practice doesn’t exist in a lot of places in Europe. The patients are sitting in the hospital here for 6 weeks, oftentimes for no other reason – just to get their IV antibiotic therapy. The POET trial has shown us that that is probably the wrong thing to be doing.”
Earlier surgical intervention
The new guidelines also recommend that “once there is an indication to do cardiac surgery, it should be promptly performed,” Dr. Borger noted.
Surgery to remove infected material and drain abscesses is indicated for patients with heart failure or uncontrolled infection and to prevent embolism.
“We have defined emergency indications that should be done within 24 hours; urgent, which should be done within 3-5 days; and nonurgent, more than 5 days but within the same hospitalization,” he elaborated. “We’re basically trying to encourage surgeons and nonsurgeons that once there is an indication for surgery, there’s not a lot of benefit to just waiting. You should proceed with operation in a timely manner” to improve survival.
The guidelines recommend surgery for early prosthetic valve endocarditis, within 6 months of valve surgery, with new valve replacement and complete debridement.
Patients who present with stroke and require surgery are not uncommon, Dr. Borger noted. Ischemic stroke should not be a reason to delay surgery, and patients with hemorrhagic stoke, with favorable features, can undergo surgery.
The guidelines provide a figure for the management of CIED-related infective endocarditis. They also include a new section devoted to patient-centered care and shared decision-making.
The guidelines were endorsed by the European Association for Cardio-Thoracic Surgery and the European Association of Nuclear Medicine. The writing task force included representatives from EACTS, EANM, and the European Society of Clinical Microbiology and Infectious Diseases.
The complete guidelines, as well as pocket guidelines, essential messages, a pocket guidelines app, and an official guidelines slide set, all addressing endocarditis, are available from the ESC website.
The guidelines did not receive any funding. The disclosure forms of all experts involved in their development are available on the ESC website.
A version of this article appeared on Medscape.com.
FROM ESC CONGRESS 2023
Acoramidis shows encouraging results in ATTR cardiomyopathy
AMSTERDAM –
The drug, acoramidis (BridgeBio Pharma), showed a significant reduction, compared with placebo, in the primary endpoint, a hierarchical analysis of all-cause mortality, cumulative frequency of cardiovascular hospitalizations, and change from baseline in N-terminal of the prohormone brain natriuretic peptide (NT-proBNP) and 6-minute walking distance, in the ATTRibute-CM trial.
The combination of all-cause mortality/cardiovascular hospitalization was also significantly reduced.
The trial was presented at the annual congress of the European Society of Cardiology by Julian Gillmore, MD, head of the University College London Centre for Amyloidosis.
“ATTRibute-CM was a robustly positive trial, showing benefits across the board for acoramidis, and suggest the tantalizing possibility of genuine clinical improvements,” Dr. Gillmore concluded.
ATTR-CM is a debilitating and progressive condition that increases mortality and reduces quality of life. Although this form of cardiomyopathy was considered to be very rare not long ago, improvements in imaging techniques and treatment developments have resulted in an upsurge in diagnosis throughout the world, and the disease is being diagnosed at an earlier stage, Dr. Gillmore noted.
ATTR-CM results from aggregation and deposition of transthyretin amyloid fibrils in the heart and various tissues. Acoramidis stabilizes the TTR tetramer and avoids the production of the fibrils.
Another similar drug, tafamidis (Vyndaqel, Vyndamax, Pfizer), was approved by the Food and Drug Administration in 2019 for ATTR-CM and is now available in several counties, including Japan and Europe.
BridgeBio Pharma is planning to file for FDA approval for acoramidis toward the end of 2023 and in other countries in 2024, Dr. Gillmore reported.
“It will be a huge benefit to patients to have another effective drug available,” he said.
Tafamidis also showed impressive results with its pivotal trial – ATTR-ACT – including a significant reduction in all-cause mortality, which was not seen in the ATTRibute-CM trial with acoramidis.
Asked about this, Dr. Gillmore replied: “It is difficult to comment on comparison with tafamidis as there isn’t a head-to-head trial. All I can say is that these results with acoramidis are fantastically encouraging, and I think we are going to have two effective drugs to treat this progressive and fatal condition.”
He elaborated that the difference in all-cause mortality results between the trials was “entirely consistent” with differences in the trial populations, with the ATTRibute-CM trial recruiting much lower-risk patients, in line with the earlier diagnosis of the condition that is now occurring.
“The survival in the placebo group in the ATTRibute study was greater than that in the treatment group in the ATTR-ACT study. So, it’s not all that surprising, given the reduced number of events, that mortality alone was not statistically significant in ATTRibute. What is important is that the trend in mortality was in the right direction, with an impressive risk reduction,” Dr. Gillmore noted.
“Incredibly, survival at 30 months and hospitalization rates among patients receiving acoramidis approached that of age-matched individuals who do not have ATTR,” he added.
Noting that more patients in the placebo group started taking tafamidis during the trial, Dr. Gillmore suggested that this would be expected to dilute the treatment effect of acoramidis.
“To have such a strongly positive study despite the change in the patient population and drop-in use of tafamidis is incredibly powerful,” he concluded.
ATTRibute trial
The randomized double-blind ATTRibute-CM trial included 632 patients with ATTR-CM and New York Heart Association class I-III heart failure.
They were randomly assigned 2:1 to acoramidis (800 mg twice daily) or placebo, with a follow-up of 30 months. After the first 12 months, tafamidis was permitted if available. This was more prevalent in the placebo arm (22% vs. 14%).
The trial met the primary endpoint – a hierarchical analysis of all-cause mortality, cumulative frequency of cardiovascular hospitalizations, and change from baseline in NT-proBNP and 6-minute walking distance – with a win ratio of 1.8, which was highly statistically significant (P < .0001).
Results were consistent across all components of the primary endpoint and across all subgroups, Dr. Gillmore reported.
“Importantly, 58% of the win ratio ties were broken by the first two components of the hierarchical analysis – all-cause mortality and cardiovascular hospitalizations – and a separate analysis of these two components alone was also statistically significant,” he noted.
A trend was seen toward a treatment effect on all-cause mortality favoring acoramidis, with an 81% survival rate in the treated group, representing an absolute risk reduction of 6.4 percentage points and a relative risk reduction of 25%.
Of the deaths reported in the study, 78% were cardiovascular in nature. Cardiovascular death also showed a trend favoring treatment with the study drug (14.9% in the acoramidis group vs. 21.3% in the placebo group), giving an absolute risk reduction of 6.4 percentage points and a relative risk reduction of 30%.
Acoramidis was also associated with 50% reduction in cardiovascular hospitalizations, which was highly significant (P < .0001).
A treatment effect was also seen in terms of functional status; at 30 months, the difference in 6-minute walk distance between the groups was 40 meters, a “highly statistically significant improvement and clinically important difference, Dr. Gillmore said. Improvement from baseline occurred in 40% of the acoramidis group versus 22% of the placebo group.
Acoramidis recipients showed a blunting of the progressive rise of NT-proBNP, which Dr. Gillmore noted has been shown to be strongly associated with outcomes, with 45% of the acoramidis treated patients showing an improvement in NT-proBNP levels, compared with 9% of placebo group.
There was also a relative preservation of quality of life in the acoramidis group consistent with the separation of NT-proBNP curves, he added.
“Consistent with the mechanism of action and preclinical data showing near-complete stabilization of TTR at therapeutic drug concentrations, serum TTR (an in vivo reflection of TTR stabilization) was promptly and persistently elevated in patients receiving acoramidis,” Dr. Gillmore said.
Safety data showed that treatment-related adverse events were equal between the two groups, and there were fewer treatment emergent serious adverse events in the acoramidis group. The drug was said to be “generally well tolerated, with no findings of potential clinical concern.”
Second primary endpoint not significant
Discussant of the study at the ESC Hotline session, Thibaud Damy, MD, Hospital Henri Mondor, Paris East Creteil University, pointed out that a second primary endpoint of the study, change from baseline to month 12 in the 6-minute walking test, did not significantly differ between acoramidis and placebo.
Dr. Damy also highlighted the significant all-cause mortality reduction seen with tafamidis in ATTR-ACT but not achieved with acoramidis in ATTRibute.
He agreed with Dr. Gillmore’s interpretation that this was probably stemmed from the ATTRibute trial recruiting lower-risk patients, pointing out that patients in this trial had lower levels of NT-proBNP and less severe heart failure.
“It is clear that there is a place for acoramidis in patients with ATTR-CM,” Dr. Damy concluded, adding that many other treatments are in development.
The ATTribute trial was supported by BridgeBio Pharma. Dr. Gillmore reported advisory/consultant roles with BridgeBio, Alnylam, Ionis, AstraZeneca, Intellia, Pfizer, ATTRalus, and Lycia.
A version of this article first appeared on Medscape.com.
AMSTERDAM –
The drug, acoramidis (BridgeBio Pharma), showed a significant reduction, compared with placebo, in the primary endpoint, a hierarchical analysis of all-cause mortality, cumulative frequency of cardiovascular hospitalizations, and change from baseline in N-terminal of the prohormone brain natriuretic peptide (NT-proBNP) and 6-minute walking distance, in the ATTRibute-CM trial.
The combination of all-cause mortality/cardiovascular hospitalization was also significantly reduced.
The trial was presented at the annual congress of the European Society of Cardiology by Julian Gillmore, MD, head of the University College London Centre for Amyloidosis.
“ATTRibute-CM was a robustly positive trial, showing benefits across the board for acoramidis, and suggest the tantalizing possibility of genuine clinical improvements,” Dr. Gillmore concluded.
ATTR-CM is a debilitating and progressive condition that increases mortality and reduces quality of life. Although this form of cardiomyopathy was considered to be very rare not long ago, improvements in imaging techniques and treatment developments have resulted in an upsurge in diagnosis throughout the world, and the disease is being diagnosed at an earlier stage, Dr. Gillmore noted.
ATTR-CM results from aggregation and deposition of transthyretin amyloid fibrils in the heart and various tissues. Acoramidis stabilizes the TTR tetramer and avoids the production of the fibrils.
Another similar drug, tafamidis (Vyndaqel, Vyndamax, Pfizer), was approved by the Food and Drug Administration in 2019 for ATTR-CM and is now available in several counties, including Japan and Europe.
BridgeBio Pharma is planning to file for FDA approval for acoramidis toward the end of 2023 and in other countries in 2024, Dr. Gillmore reported.
“It will be a huge benefit to patients to have another effective drug available,” he said.
Tafamidis also showed impressive results with its pivotal trial – ATTR-ACT – including a significant reduction in all-cause mortality, which was not seen in the ATTRibute-CM trial with acoramidis.
Asked about this, Dr. Gillmore replied: “It is difficult to comment on comparison with tafamidis as there isn’t a head-to-head trial. All I can say is that these results with acoramidis are fantastically encouraging, and I think we are going to have two effective drugs to treat this progressive and fatal condition.”
He elaborated that the difference in all-cause mortality results between the trials was “entirely consistent” with differences in the trial populations, with the ATTRibute-CM trial recruiting much lower-risk patients, in line with the earlier diagnosis of the condition that is now occurring.
“The survival in the placebo group in the ATTRibute study was greater than that in the treatment group in the ATTR-ACT study. So, it’s not all that surprising, given the reduced number of events, that mortality alone was not statistically significant in ATTRibute. What is important is that the trend in mortality was in the right direction, with an impressive risk reduction,” Dr. Gillmore noted.
“Incredibly, survival at 30 months and hospitalization rates among patients receiving acoramidis approached that of age-matched individuals who do not have ATTR,” he added.
Noting that more patients in the placebo group started taking tafamidis during the trial, Dr. Gillmore suggested that this would be expected to dilute the treatment effect of acoramidis.
“To have such a strongly positive study despite the change in the patient population and drop-in use of tafamidis is incredibly powerful,” he concluded.
ATTRibute trial
The randomized double-blind ATTRibute-CM trial included 632 patients with ATTR-CM and New York Heart Association class I-III heart failure.
They were randomly assigned 2:1 to acoramidis (800 mg twice daily) or placebo, with a follow-up of 30 months. After the first 12 months, tafamidis was permitted if available. This was more prevalent in the placebo arm (22% vs. 14%).
The trial met the primary endpoint – a hierarchical analysis of all-cause mortality, cumulative frequency of cardiovascular hospitalizations, and change from baseline in NT-proBNP and 6-minute walking distance – with a win ratio of 1.8, which was highly statistically significant (P < .0001).
Results were consistent across all components of the primary endpoint and across all subgroups, Dr. Gillmore reported.
“Importantly, 58% of the win ratio ties were broken by the first two components of the hierarchical analysis – all-cause mortality and cardiovascular hospitalizations – and a separate analysis of these two components alone was also statistically significant,” he noted.
A trend was seen toward a treatment effect on all-cause mortality favoring acoramidis, with an 81% survival rate in the treated group, representing an absolute risk reduction of 6.4 percentage points and a relative risk reduction of 25%.
Of the deaths reported in the study, 78% were cardiovascular in nature. Cardiovascular death also showed a trend favoring treatment with the study drug (14.9% in the acoramidis group vs. 21.3% in the placebo group), giving an absolute risk reduction of 6.4 percentage points and a relative risk reduction of 30%.
Acoramidis was also associated with 50% reduction in cardiovascular hospitalizations, which was highly significant (P < .0001).
A treatment effect was also seen in terms of functional status; at 30 months, the difference in 6-minute walk distance between the groups was 40 meters, a “highly statistically significant improvement and clinically important difference, Dr. Gillmore said. Improvement from baseline occurred in 40% of the acoramidis group versus 22% of the placebo group.
Acoramidis recipients showed a blunting of the progressive rise of NT-proBNP, which Dr. Gillmore noted has been shown to be strongly associated with outcomes, with 45% of the acoramidis treated patients showing an improvement in NT-proBNP levels, compared with 9% of placebo group.
There was also a relative preservation of quality of life in the acoramidis group consistent with the separation of NT-proBNP curves, he added.
“Consistent with the mechanism of action and preclinical data showing near-complete stabilization of TTR at therapeutic drug concentrations, serum TTR (an in vivo reflection of TTR stabilization) was promptly and persistently elevated in patients receiving acoramidis,” Dr. Gillmore said.
Safety data showed that treatment-related adverse events were equal between the two groups, and there were fewer treatment emergent serious adverse events in the acoramidis group. The drug was said to be “generally well tolerated, with no findings of potential clinical concern.”
Second primary endpoint not significant
Discussant of the study at the ESC Hotline session, Thibaud Damy, MD, Hospital Henri Mondor, Paris East Creteil University, pointed out that a second primary endpoint of the study, change from baseline to month 12 in the 6-minute walking test, did not significantly differ between acoramidis and placebo.
Dr. Damy also highlighted the significant all-cause mortality reduction seen with tafamidis in ATTR-ACT but not achieved with acoramidis in ATTRibute.
He agreed with Dr. Gillmore’s interpretation that this was probably stemmed from the ATTRibute trial recruiting lower-risk patients, pointing out that patients in this trial had lower levels of NT-proBNP and less severe heart failure.
“It is clear that there is a place for acoramidis in patients with ATTR-CM,” Dr. Damy concluded, adding that many other treatments are in development.
The ATTribute trial was supported by BridgeBio Pharma. Dr. Gillmore reported advisory/consultant roles with BridgeBio, Alnylam, Ionis, AstraZeneca, Intellia, Pfizer, ATTRalus, and Lycia.
A version of this article first appeared on Medscape.com.
AMSTERDAM –
The drug, acoramidis (BridgeBio Pharma), showed a significant reduction, compared with placebo, in the primary endpoint, a hierarchical analysis of all-cause mortality, cumulative frequency of cardiovascular hospitalizations, and change from baseline in N-terminal of the prohormone brain natriuretic peptide (NT-proBNP) and 6-minute walking distance, in the ATTRibute-CM trial.
The combination of all-cause mortality/cardiovascular hospitalization was also significantly reduced.
The trial was presented at the annual congress of the European Society of Cardiology by Julian Gillmore, MD, head of the University College London Centre for Amyloidosis.
“ATTRibute-CM was a robustly positive trial, showing benefits across the board for acoramidis, and suggest the tantalizing possibility of genuine clinical improvements,” Dr. Gillmore concluded.
ATTR-CM is a debilitating and progressive condition that increases mortality and reduces quality of life. Although this form of cardiomyopathy was considered to be very rare not long ago, improvements in imaging techniques and treatment developments have resulted in an upsurge in diagnosis throughout the world, and the disease is being diagnosed at an earlier stage, Dr. Gillmore noted.
ATTR-CM results from aggregation and deposition of transthyretin amyloid fibrils in the heart and various tissues. Acoramidis stabilizes the TTR tetramer and avoids the production of the fibrils.
Another similar drug, tafamidis (Vyndaqel, Vyndamax, Pfizer), was approved by the Food and Drug Administration in 2019 for ATTR-CM and is now available in several counties, including Japan and Europe.
BridgeBio Pharma is planning to file for FDA approval for acoramidis toward the end of 2023 and in other countries in 2024, Dr. Gillmore reported.
“It will be a huge benefit to patients to have another effective drug available,” he said.
Tafamidis also showed impressive results with its pivotal trial – ATTR-ACT – including a significant reduction in all-cause mortality, which was not seen in the ATTRibute-CM trial with acoramidis.
Asked about this, Dr. Gillmore replied: “It is difficult to comment on comparison with tafamidis as there isn’t a head-to-head trial. All I can say is that these results with acoramidis are fantastically encouraging, and I think we are going to have two effective drugs to treat this progressive and fatal condition.”
He elaborated that the difference in all-cause mortality results between the trials was “entirely consistent” with differences in the trial populations, with the ATTRibute-CM trial recruiting much lower-risk patients, in line with the earlier diagnosis of the condition that is now occurring.
“The survival in the placebo group in the ATTRibute study was greater than that in the treatment group in the ATTR-ACT study. So, it’s not all that surprising, given the reduced number of events, that mortality alone was not statistically significant in ATTRibute. What is important is that the trend in mortality was in the right direction, with an impressive risk reduction,” Dr. Gillmore noted.
“Incredibly, survival at 30 months and hospitalization rates among patients receiving acoramidis approached that of age-matched individuals who do not have ATTR,” he added.
Noting that more patients in the placebo group started taking tafamidis during the trial, Dr. Gillmore suggested that this would be expected to dilute the treatment effect of acoramidis.
“To have such a strongly positive study despite the change in the patient population and drop-in use of tafamidis is incredibly powerful,” he concluded.
ATTRibute trial
The randomized double-blind ATTRibute-CM trial included 632 patients with ATTR-CM and New York Heart Association class I-III heart failure.
They were randomly assigned 2:1 to acoramidis (800 mg twice daily) or placebo, with a follow-up of 30 months. After the first 12 months, tafamidis was permitted if available. This was more prevalent in the placebo arm (22% vs. 14%).
The trial met the primary endpoint – a hierarchical analysis of all-cause mortality, cumulative frequency of cardiovascular hospitalizations, and change from baseline in NT-proBNP and 6-minute walking distance – with a win ratio of 1.8, which was highly statistically significant (P < .0001).
Results were consistent across all components of the primary endpoint and across all subgroups, Dr. Gillmore reported.
“Importantly, 58% of the win ratio ties were broken by the first two components of the hierarchical analysis – all-cause mortality and cardiovascular hospitalizations – and a separate analysis of these two components alone was also statistically significant,” he noted.
A trend was seen toward a treatment effect on all-cause mortality favoring acoramidis, with an 81% survival rate in the treated group, representing an absolute risk reduction of 6.4 percentage points and a relative risk reduction of 25%.
Of the deaths reported in the study, 78% were cardiovascular in nature. Cardiovascular death also showed a trend favoring treatment with the study drug (14.9% in the acoramidis group vs. 21.3% in the placebo group), giving an absolute risk reduction of 6.4 percentage points and a relative risk reduction of 30%.
Acoramidis was also associated with 50% reduction in cardiovascular hospitalizations, which was highly significant (P < .0001).
A treatment effect was also seen in terms of functional status; at 30 months, the difference in 6-minute walk distance between the groups was 40 meters, a “highly statistically significant improvement and clinically important difference, Dr. Gillmore said. Improvement from baseline occurred in 40% of the acoramidis group versus 22% of the placebo group.
Acoramidis recipients showed a blunting of the progressive rise of NT-proBNP, which Dr. Gillmore noted has been shown to be strongly associated with outcomes, with 45% of the acoramidis treated patients showing an improvement in NT-proBNP levels, compared with 9% of placebo group.
There was also a relative preservation of quality of life in the acoramidis group consistent with the separation of NT-proBNP curves, he added.
“Consistent with the mechanism of action and preclinical data showing near-complete stabilization of TTR at therapeutic drug concentrations, serum TTR (an in vivo reflection of TTR stabilization) was promptly and persistently elevated in patients receiving acoramidis,” Dr. Gillmore said.
Safety data showed that treatment-related adverse events were equal between the two groups, and there were fewer treatment emergent serious adverse events in the acoramidis group. The drug was said to be “generally well tolerated, with no findings of potential clinical concern.”
Second primary endpoint not significant
Discussant of the study at the ESC Hotline session, Thibaud Damy, MD, Hospital Henri Mondor, Paris East Creteil University, pointed out that a second primary endpoint of the study, change from baseline to month 12 in the 6-minute walking test, did not significantly differ between acoramidis and placebo.
Dr. Damy also highlighted the significant all-cause mortality reduction seen with tafamidis in ATTR-ACT but not achieved with acoramidis in ATTRibute.
He agreed with Dr. Gillmore’s interpretation that this was probably stemmed from the ATTRibute trial recruiting lower-risk patients, pointing out that patients in this trial had lower levels of NT-proBNP and less severe heart failure.
“It is clear that there is a place for acoramidis in patients with ATTR-CM,” Dr. Damy concluded, adding that many other treatments are in development.
The ATTribute trial was supported by BridgeBio Pharma. Dr. Gillmore reported advisory/consultant roles with BridgeBio, Alnylam, Ionis, AstraZeneca, Intellia, Pfizer, ATTRalus, and Lycia.
A version of this article first appeared on Medscape.com.
AT THE ESC CONGRESS 2023
AAP’s hearing test clinical update is the first since 2009
The update is the first since 2009.
The AAP’s clinical report was published online in Pediatrics.
Charles Bower, MD, with the department of otolaryngology at Arkansas Children’s Hospital in Little Rock, led the research team representing AAP’s Committee on Practice and Ambulatory Medicine, section on otolaryngology and head and neck surgery.
The report details how primary care clinicians can detect changes in hearing status by age.
Eliminating terms such as ‘failed’ or ‘impairment’
A key change in this report is that it no longer uses terms such as “loss,” “failed,” or “impairment,” “to reflect that children who are deaf or hard of hearing (D/HH) are equal, healthy, and whole,” the authors wrote.
The report’s recommendations are based on the literature and engagement with deaf and hard of hearing professionals and partner organizations, such as the National Association of the Deaf, working with the AAP Early Hearing Detection and Intervention program.
Birth to 5 a critical time
The authors noted that early medical support for hearing is especially important between birth and 5 years of age. That span is a critical time for brain and language development.
Parents and caregivers are often the first to notice a child’s inattention or erratic responses to sound, they wrote, and it’s important to address these concerns with a pediatrician even if the child has passed a newborn hearing test after birth.
Among recommendations in the update:
- All children should have an objective, evidence-based risk assessment for changes in hearing.
- Children at all ages should have prompt screening if there is clinical or caregiver concern about hearing.
- A child who screens positive for atypical hearing in one or both ears should be referred to an audiologist for diagnostic consultation and testing.
- Because standard testing for children with developmental or behavioral health conditions may be impossible or inaccurate, referral may be more appropriate to audiology for electrophysiological hearing testing using auditory brainstem response (ABR) with sedation.
- To prevent false negatives and to avoid delays in identification, access to language, and support, screening tests should not be repeated more than once before referral to audiology.
Additional recommendations
The report authors pointed out that genetic causes may affect hearing and may show up beyond the newborn period.
They wrote that congenital cytomegalovirus (cCMV) infection is the most common infectious cause of childhood sensorineural hearing change and accounts for 25% of deaf and hard of hearing children at age 4.
Meningitis and otitis media also are leading causes of a change in hearing.
Judith E.C. Lieu, MD, MSPH, professor, program director and vice-chair for education in the department of otolaryngology and head and neck surgery at Washington University in St. Louis, who was not part of the research team, said screening recommendations have not changed much in the update, but she highlighted some points.
She noted that tympanometry is not listed as a method of hearing screening in primary care.
“I agree that tympanogram is not a hearing screening. It is an adjunct to look at middle ear function, but that doesn’t necessarily mean it looks for hearing,” she said.
Dr. Lieu says she does take issue with the stated length of one of the tests in the paper. She said she is concerned that the pure-tone audiometry test for ages 4 through adolescence is listed as taking 30 minutes in a primary care setting. She said she worries that pediatricians will be put off by reading that it is a 30-minute test.
“Honestly, in my experience, it doesn’t take 30 minutes. Maybe 10 minutes,” she said. “I don’t know any pediatrician who could devote 30 minutes to one screening test.”
Development milestones have been adjusted
Also different in these recommendations are the developmental and speech milestones updated according to the most recent AAP information, Dr. Lieu said. Though the new milestones don’t change by much, they are important to note, she said, such as updated guidance on when to be concerned about speech delay.
She said she wished the guidance included more about hearing loss in older children.
The report authors stated that about 1 to 3 per 1,000 children have atypical hearing at birth and similar numbers become deaf or hard of hearing later in childhood.
But Dr. Lieu says that statistic may give the wrong impression about frequency of atypical hearing.
“Hearing loss increases during childhood,” she pointed out. “By the time they hit about age 18, about 15% of kids have some kind of hearing loss.”
“I don’t think it’s made clear to pediatricians that this is not 1 or 2 in a thousand children – this happens much more frequently,” she said.
The report authors and Dr. Lieu report no relevant financial relationships.
The update is the first since 2009.
The AAP’s clinical report was published online in Pediatrics.
Charles Bower, MD, with the department of otolaryngology at Arkansas Children’s Hospital in Little Rock, led the research team representing AAP’s Committee on Practice and Ambulatory Medicine, section on otolaryngology and head and neck surgery.
The report details how primary care clinicians can detect changes in hearing status by age.
Eliminating terms such as ‘failed’ or ‘impairment’
A key change in this report is that it no longer uses terms such as “loss,” “failed,” or “impairment,” “to reflect that children who are deaf or hard of hearing (D/HH) are equal, healthy, and whole,” the authors wrote.
The report’s recommendations are based on the literature and engagement with deaf and hard of hearing professionals and partner organizations, such as the National Association of the Deaf, working with the AAP Early Hearing Detection and Intervention program.
Birth to 5 a critical time
The authors noted that early medical support for hearing is especially important between birth and 5 years of age. That span is a critical time for brain and language development.
Parents and caregivers are often the first to notice a child’s inattention or erratic responses to sound, they wrote, and it’s important to address these concerns with a pediatrician even if the child has passed a newborn hearing test after birth.
Among recommendations in the update:
- All children should have an objective, evidence-based risk assessment for changes in hearing.
- Children at all ages should have prompt screening if there is clinical or caregiver concern about hearing.
- A child who screens positive for atypical hearing in one or both ears should be referred to an audiologist for diagnostic consultation and testing.
- Because standard testing for children with developmental or behavioral health conditions may be impossible or inaccurate, referral may be more appropriate to audiology for electrophysiological hearing testing using auditory brainstem response (ABR) with sedation.
- To prevent false negatives and to avoid delays in identification, access to language, and support, screening tests should not be repeated more than once before referral to audiology.
Additional recommendations
The report authors pointed out that genetic causes may affect hearing and may show up beyond the newborn period.
They wrote that congenital cytomegalovirus (cCMV) infection is the most common infectious cause of childhood sensorineural hearing change and accounts for 25% of deaf and hard of hearing children at age 4.
Meningitis and otitis media also are leading causes of a change in hearing.
Judith E.C. Lieu, MD, MSPH, professor, program director and vice-chair for education in the department of otolaryngology and head and neck surgery at Washington University in St. Louis, who was not part of the research team, said screening recommendations have not changed much in the update, but she highlighted some points.
She noted that tympanometry is not listed as a method of hearing screening in primary care.
“I agree that tympanogram is not a hearing screening. It is an adjunct to look at middle ear function, but that doesn’t necessarily mean it looks for hearing,” she said.
Dr. Lieu says she does take issue with the stated length of one of the tests in the paper. She said she is concerned that the pure-tone audiometry test for ages 4 through adolescence is listed as taking 30 minutes in a primary care setting. She said she worries that pediatricians will be put off by reading that it is a 30-minute test.
“Honestly, in my experience, it doesn’t take 30 minutes. Maybe 10 minutes,” she said. “I don’t know any pediatrician who could devote 30 minutes to one screening test.”
Development milestones have been adjusted
Also different in these recommendations are the developmental and speech milestones updated according to the most recent AAP information, Dr. Lieu said. Though the new milestones don’t change by much, they are important to note, she said, such as updated guidance on when to be concerned about speech delay.
She said she wished the guidance included more about hearing loss in older children.
The report authors stated that about 1 to 3 per 1,000 children have atypical hearing at birth and similar numbers become deaf or hard of hearing later in childhood.
But Dr. Lieu says that statistic may give the wrong impression about frequency of atypical hearing.
“Hearing loss increases during childhood,” she pointed out. “By the time they hit about age 18, about 15% of kids have some kind of hearing loss.”
“I don’t think it’s made clear to pediatricians that this is not 1 or 2 in a thousand children – this happens much more frequently,” she said.
The report authors and Dr. Lieu report no relevant financial relationships.
The update is the first since 2009.
The AAP’s clinical report was published online in Pediatrics.
Charles Bower, MD, with the department of otolaryngology at Arkansas Children’s Hospital in Little Rock, led the research team representing AAP’s Committee on Practice and Ambulatory Medicine, section on otolaryngology and head and neck surgery.
The report details how primary care clinicians can detect changes in hearing status by age.
Eliminating terms such as ‘failed’ or ‘impairment’
A key change in this report is that it no longer uses terms such as “loss,” “failed,” or “impairment,” “to reflect that children who are deaf or hard of hearing (D/HH) are equal, healthy, and whole,” the authors wrote.
The report’s recommendations are based on the literature and engagement with deaf and hard of hearing professionals and partner organizations, such as the National Association of the Deaf, working with the AAP Early Hearing Detection and Intervention program.
Birth to 5 a critical time
The authors noted that early medical support for hearing is especially important between birth and 5 years of age. That span is a critical time for brain and language development.
Parents and caregivers are often the first to notice a child’s inattention or erratic responses to sound, they wrote, and it’s important to address these concerns with a pediatrician even if the child has passed a newborn hearing test after birth.
Among recommendations in the update:
- All children should have an objective, evidence-based risk assessment for changes in hearing.
- Children at all ages should have prompt screening if there is clinical or caregiver concern about hearing.
- A child who screens positive for atypical hearing in one or both ears should be referred to an audiologist for diagnostic consultation and testing.
- Because standard testing for children with developmental or behavioral health conditions may be impossible or inaccurate, referral may be more appropriate to audiology for electrophysiological hearing testing using auditory brainstem response (ABR) with sedation.
- To prevent false negatives and to avoid delays in identification, access to language, and support, screening tests should not be repeated more than once before referral to audiology.
Additional recommendations
The report authors pointed out that genetic causes may affect hearing and may show up beyond the newborn period.
They wrote that congenital cytomegalovirus (cCMV) infection is the most common infectious cause of childhood sensorineural hearing change and accounts for 25% of deaf and hard of hearing children at age 4.
Meningitis and otitis media also are leading causes of a change in hearing.
Judith E.C. Lieu, MD, MSPH, professor, program director and vice-chair for education in the department of otolaryngology and head and neck surgery at Washington University in St. Louis, who was not part of the research team, said screening recommendations have not changed much in the update, but she highlighted some points.
She noted that tympanometry is not listed as a method of hearing screening in primary care.
“I agree that tympanogram is not a hearing screening. It is an adjunct to look at middle ear function, but that doesn’t necessarily mean it looks for hearing,” she said.
Dr. Lieu says she does take issue with the stated length of one of the tests in the paper. She said she is concerned that the pure-tone audiometry test for ages 4 through adolescence is listed as taking 30 minutes in a primary care setting. She said she worries that pediatricians will be put off by reading that it is a 30-minute test.
“Honestly, in my experience, it doesn’t take 30 minutes. Maybe 10 minutes,” she said. “I don’t know any pediatrician who could devote 30 minutes to one screening test.”
Development milestones have been adjusted
Also different in these recommendations are the developmental and speech milestones updated according to the most recent AAP information, Dr. Lieu said. Though the new milestones don’t change by much, they are important to note, she said, such as updated guidance on when to be concerned about speech delay.
She said she wished the guidance included more about hearing loss in older children.
The report authors stated that about 1 to 3 per 1,000 children have atypical hearing at birth and similar numbers become deaf or hard of hearing later in childhood.
But Dr. Lieu says that statistic may give the wrong impression about frequency of atypical hearing.
“Hearing loss increases during childhood,” she pointed out. “By the time they hit about age 18, about 15% of kids have some kind of hearing loss.”
“I don’t think it’s made clear to pediatricians that this is not 1 or 2 in a thousand children – this happens much more frequently,” she said.
The report authors and Dr. Lieu report no relevant financial relationships.
FROM PEDIATRICS
Answering the protein question when prescribing plant-based diets
Science supports the use of a whole food, predominantly plant-based dietary pattern for optimal health, including reduced risk for chronic disease, and best practice in treatment of leading chronic disease.
We’ve all heard it, and it’s understandable. Patients know that protein is essential for their health and strength, and animal foods have developed a reputation for being the premier protein sources that humans should prioritize through diet. But widespread misconceptions about human needs for protein have inaccurately equated animal food as the best and only sources of protein, augmented by fad diets and modern food marketing. All of this leads to confusion about how much protein people should actually consume and the quality of protein found in plant foods, making many patients reluctant to fully embrace a whole food, predominately plant-based diet.
To ensure that patients have all the facts when making dietary decisions, clinicians need to be prepared to respond to concerns about protein adequacy and quality with evidence-based information. A good starting point for these conversations is to assess how much protein patients are already consuming. A review of the 2015-2016 National Health and Nutrition Examination Survey found that women normally consume an average of 69 g and men an average of 97 g of protein daily.
As a general point of reference, the recommended dietary allowance for protein is about 0.8 g/kg of bodyweight (or 0.36 g/lb), which equates to about 52 g of protein per day for a 145-lb woman and 65 g for a 180-lb man. But for many patients, it may be best to get a more precise recommendation based upon age, gender and physical activity level by using a handy Department of Agriculture tool for health care professionals to calculate daily protein and other nutrient needs. Patients can also use one of countless apps to track their protein and other nutrient intake. By using the tool and a tracking app, both clinician and patients can be fully informed whether protein needs are being met.
The recommended daily allowances for protein are easily met by consuming a variety of whole plant foods, including a variety of minimally processed vegetables, fruits, whole grains, legumes, nuts, and seeds. One cup of cooked red lentils or black beans, for example, contains between 15 g and 18 g of protein. A quarter cup of almonds contains about 7 g of protein and one cup of cooked oats has 5 g.
What about those amino acids?
An area of contention around plant food protein is “complete versus incomplete protein,” terms used to describe whether a protein contains all nine essential amino acids that our bodies require from a single source. Animal food sources usually contain all the essential amino acids, whereas plant sources of protein may contain varying amounts of these amino acids or may even be missing some.
This leads to a misconception that someone adopting a diet of predominately plant food may have to stack or combine specific plant foods in a meal to ensure their protein intake includes an appropriate proportion of amino acids. But the process of protein breakdown turnover solves this problem. The body continuously breaks down protein and recombines it with amino acids stored in tissue for use when needed. Once absorbed by the small intestine, it doesn’t matter whether the protein or amino acids came from the same meal. As long as a person is eating a variety of plant-based protein sources, they will consume adequate amounts of all essential amino acids.
This is true even for athletes, older adults and pregnant women. It is also the position of the Academy of Nutrition and Dietetics that a whole-food, predominately plant-based eating pattern is appropriate for athletes and “all stages of the life cycle, including pregnancy, lactation, infancy, childhood, adolescence, older adulthood.”
The plant-based diet
For examples of healthy plant-based eating plans, The American College of Lifestyle Medicine offers a complimentary guide for a whole food, predominantly plant-based diet that demonstrates how easily the recommended dietary allowance of protein is satisfied. A breakfast of rolled oats, a lunch of bean burritos, and a dinner of mashed potatoes, with chickpeas with a couple snacks throughout the day, adds up to 71 g of protein. Other plant-based meal plans top 100 g or 90 g, with all meal plans meeting or surpassing recommended allowances.
Along with the protein, plant food delivers other beneficial nutrients and dietary components like fiber, antioxidants, anti-inflammatory properties, various vitamins and nutrients, and phytochemicals and vitamin D, without the saturated fats and sodium in meat. But U.S. adults get approximately two-thirds of their protein from animal sources, which lack fiber and have higher levels of saturated fats or sodium that can raise cholesterol and increase the risks for heart disease and stroke.
For clinicians, ACLM published a 10-part series of research white papers on the benefits of a whole food, plant-predominant dietary lifestyle and offers a catalogue of food as medicine continuing medical education and continuing education courses.
Patients hunger for knowledge about health-promoting nutrition but may have difficulty sorting myths from evidence-based facts. Each healthcare professional has an important and powerful opportunity to steer patients in a healthier direction through their diet.
Dr. Collings is director of lifestyle medicine, Silicon Valley Medical Development; President, American College of Lifestyle Medicine, Mountain View, Calif. She has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
Science supports the use of a whole food, predominantly plant-based dietary pattern for optimal health, including reduced risk for chronic disease, and best practice in treatment of leading chronic disease.
We’ve all heard it, and it’s understandable. Patients know that protein is essential for their health and strength, and animal foods have developed a reputation for being the premier protein sources that humans should prioritize through diet. But widespread misconceptions about human needs for protein have inaccurately equated animal food as the best and only sources of protein, augmented by fad diets and modern food marketing. All of this leads to confusion about how much protein people should actually consume and the quality of protein found in plant foods, making many patients reluctant to fully embrace a whole food, predominately plant-based diet.
To ensure that patients have all the facts when making dietary decisions, clinicians need to be prepared to respond to concerns about protein adequacy and quality with evidence-based information. A good starting point for these conversations is to assess how much protein patients are already consuming. A review of the 2015-2016 National Health and Nutrition Examination Survey found that women normally consume an average of 69 g and men an average of 97 g of protein daily.
As a general point of reference, the recommended dietary allowance for protein is about 0.8 g/kg of bodyweight (or 0.36 g/lb), which equates to about 52 g of protein per day for a 145-lb woman and 65 g for a 180-lb man. But for many patients, it may be best to get a more precise recommendation based upon age, gender and physical activity level by using a handy Department of Agriculture tool for health care professionals to calculate daily protein and other nutrient needs. Patients can also use one of countless apps to track their protein and other nutrient intake. By using the tool and a tracking app, both clinician and patients can be fully informed whether protein needs are being met.
The recommended daily allowances for protein are easily met by consuming a variety of whole plant foods, including a variety of minimally processed vegetables, fruits, whole grains, legumes, nuts, and seeds. One cup of cooked red lentils or black beans, for example, contains between 15 g and 18 g of protein. A quarter cup of almonds contains about 7 g of protein and one cup of cooked oats has 5 g.
What about those amino acids?
An area of contention around plant food protein is “complete versus incomplete protein,” terms used to describe whether a protein contains all nine essential amino acids that our bodies require from a single source. Animal food sources usually contain all the essential amino acids, whereas plant sources of protein may contain varying amounts of these amino acids or may even be missing some.
This leads to a misconception that someone adopting a diet of predominately plant food may have to stack or combine specific plant foods in a meal to ensure their protein intake includes an appropriate proportion of amino acids. But the process of protein breakdown turnover solves this problem. The body continuously breaks down protein and recombines it with amino acids stored in tissue for use when needed. Once absorbed by the small intestine, it doesn’t matter whether the protein or amino acids came from the same meal. As long as a person is eating a variety of plant-based protein sources, they will consume adequate amounts of all essential amino acids.
This is true even for athletes, older adults and pregnant women. It is also the position of the Academy of Nutrition and Dietetics that a whole-food, predominately plant-based eating pattern is appropriate for athletes and “all stages of the life cycle, including pregnancy, lactation, infancy, childhood, adolescence, older adulthood.”
The plant-based diet
For examples of healthy plant-based eating plans, The American College of Lifestyle Medicine offers a complimentary guide for a whole food, predominantly plant-based diet that demonstrates how easily the recommended dietary allowance of protein is satisfied. A breakfast of rolled oats, a lunch of bean burritos, and a dinner of mashed potatoes, with chickpeas with a couple snacks throughout the day, adds up to 71 g of protein. Other plant-based meal plans top 100 g or 90 g, with all meal plans meeting or surpassing recommended allowances.
Along with the protein, plant food delivers other beneficial nutrients and dietary components like fiber, antioxidants, anti-inflammatory properties, various vitamins and nutrients, and phytochemicals and vitamin D, without the saturated fats and sodium in meat. But U.S. adults get approximately two-thirds of their protein from animal sources, which lack fiber and have higher levels of saturated fats or sodium that can raise cholesterol and increase the risks for heart disease and stroke.
For clinicians, ACLM published a 10-part series of research white papers on the benefits of a whole food, plant-predominant dietary lifestyle and offers a catalogue of food as medicine continuing medical education and continuing education courses.
Patients hunger for knowledge about health-promoting nutrition but may have difficulty sorting myths from evidence-based facts. Each healthcare professional has an important and powerful opportunity to steer patients in a healthier direction through their diet.
Dr. Collings is director of lifestyle medicine, Silicon Valley Medical Development; President, American College of Lifestyle Medicine, Mountain View, Calif. She has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
Science supports the use of a whole food, predominantly plant-based dietary pattern for optimal health, including reduced risk for chronic disease, and best practice in treatment of leading chronic disease.
We’ve all heard it, and it’s understandable. Patients know that protein is essential for their health and strength, and animal foods have developed a reputation for being the premier protein sources that humans should prioritize through diet. But widespread misconceptions about human needs for protein have inaccurately equated animal food as the best and only sources of protein, augmented by fad diets and modern food marketing. All of this leads to confusion about how much protein people should actually consume and the quality of protein found in plant foods, making many patients reluctant to fully embrace a whole food, predominately plant-based diet.
To ensure that patients have all the facts when making dietary decisions, clinicians need to be prepared to respond to concerns about protein adequacy and quality with evidence-based information. A good starting point for these conversations is to assess how much protein patients are already consuming. A review of the 2015-2016 National Health and Nutrition Examination Survey found that women normally consume an average of 69 g and men an average of 97 g of protein daily.
As a general point of reference, the recommended dietary allowance for protein is about 0.8 g/kg of bodyweight (or 0.36 g/lb), which equates to about 52 g of protein per day for a 145-lb woman and 65 g for a 180-lb man. But for many patients, it may be best to get a more precise recommendation based upon age, gender and physical activity level by using a handy Department of Agriculture tool for health care professionals to calculate daily protein and other nutrient needs. Patients can also use one of countless apps to track their protein and other nutrient intake. By using the tool and a tracking app, both clinician and patients can be fully informed whether protein needs are being met.
The recommended daily allowances for protein are easily met by consuming a variety of whole plant foods, including a variety of minimally processed vegetables, fruits, whole grains, legumes, nuts, and seeds. One cup of cooked red lentils or black beans, for example, contains between 15 g and 18 g of protein. A quarter cup of almonds contains about 7 g of protein and one cup of cooked oats has 5 g.
What about those amino acids?
An area of contention around plant food protein is “complete versus incomplete protein,” terms used to describe whether a protein contains all nine essential amino acids that our bodies require from a single source. Animal food sources usually contain all the essential amino acids, whereas plant sources of protein may contain varying amounts of these amino acids or may even be missing some.
This leads to a misconception that someone adopting a diet of predominately plant food may have to stack or combine specific plant foods in a meal to ensure their protein intake includes an appropriate proportion of amino acids. But the process of protein breakdown turnover solves this problem. The body continuously breaks down protein and recombines it with amino acids stored in tissue for use when needed. Once absorbed by the small intestine, it doesn’t matter whether the protein or amino acids came from the same meal. As long as a person is eating a variety of plant-based protein sources, they will consume adequate amounts of all essential amino acids.
This is true even for athletes, older adults and pregnant women. It is also the position of the Academy of Nutrition and Dietetics that a whole-food, predominately plant-based eating pattern is appropriate for athletes and “all stages of the life cycle, including pregnancy, lactation, infancy, childhood, adolescence, older adulthood.”
The plant-based diet
For examples of healthy plant-based eating plans, The American College of Lifestyle Medicine offers a complimentary guide for a whole food, predominantly plant-based diet that demonstrates how easily the recommended dietary allowance of protein is satisfied. A breakfast of rolled oats, a lunch of bean burritos, and a dinner of mashed potatoes, with chickpeas with a couple snacks throughout the day, adds up to 71 g of protein. Other plant-based meal plans top 100 g or 90 g, with all meal plans meeting or surpassing recommended allowances.
Along with the protein, plant food delivers other beneficial nutrients and dietary components like fiber, antioxidants, anti-inflammatory properties, various vitamins and nutrients, and phytochemicals and vitamin D, without the saturated fats and sodium in meat. But U.S. adults get approximately two-thirds of their protein from animal sources, which lack fiber and have higher levels of saturated fats or sodium that can raise cholesterol and increase the risks for heart disease and stroke.
For clinicians, ACLM published a 10-part series of research white papers on the benefits of a whole food, plant-predominant dietary lifestyle and offers a catalogue of food as medicine continuing medical education and continuing education courses.
Patients hunger for knowledge about health-promoting nutrition but may have difficulty sorting myths from evidence-based facts. Each healthcare professional has an important and powerful opportunity to steer patients in a healthier direction through their diet.
Dr. Collings is director of lifestyle medicine, Silicon Valley Medical Development; President, American College of Lifestyle Medicine, Mountain View, Calif. She has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
Risky drinking common in cancer survivors
An analysis of more than 15,000 adults with a cancer diagnosis revealed that nearly 80% were current drinkers. Among current drinkers, 13% consumed a moderate amount of alcohol in a typical day, while close to 40% engaged in hazardous drinking.
The numbers are “staggering,” Yin Cao, ScD, MPH, of Washington University in St. Louis, said in an interview. “Most concerning is that those on cancer treatment are engaged in a similar level of risky drinking.”
The study was published online in JAMA Network Open.
Drinking alcohol can increase a person’s risk for a variety of cancers, including oral and pharyngeal cancer as well as esophageal, colorectal, liver, and female breast cancers.
Consuming alcohol is also associated with numerous risks among people diagnosed with cancer. In the short term, alcohol consumption can worsen postsurgical outcomes as well as impair cognition and amplify cardiotoxicity in patients undergoing chemotherapy. In the long term, drinking alcohol can elevate a person’s risk of recurrence, secondary tumors, and mortality.
The American Society of Clinical Oncology recently issued a statement reinforcing the need to prioritize alcohol consumption as a key modifiable behavioral factor in the cancer control research agenda.
The current American Cancer Society guidelines indicate that it’s best to avoid or, at least, minimize alcohol consumption. Men should limit their intake to no more than two drinks per day and women should have no more than one drink per day.
Despite this data and guidelines, alcohol drinking patterns among cancer survivors in the United States remain poorly understood.
To explore further, the researchers identified 15,199 adult cancer survivors enrolled in the National Institutes of Health’s All of Us Research Program.
Overall, 78% of the cohort – more than 11,800 individuals – were current drinkers. In a typical day, 24% engaged in binge drinking – consuming six or more drinks on a single occasion – and 38% engaged in hazardous drinking. Using the Alcohol Use Disorders Identification Test–Consumption, the researchers classified hazardous drinking as scores of 4 or higher in men and 3 or higher in women.
Drinking patterns looked similar in the subset of 1,839 patients undergoing cancer treatment. In this group, 76% were current drinkers. Among current drinkers, 12% exceeded moderate drinking levels, 23% reported binge drinking, and 38% engaged in hazardous drinking. In this group, men, Hispanics, people diagnosed with cancer before age 18, and smokers were more likely to engage in risky drinking behaviors.
“We know that many people who are diagnosed with cancer continue to drink alcohol, but this study provides much more detailed information about that,” said Farhad Islami, MD, PhD, senior scientific director for cancer disparity research at the American Cancer Society, Atlanta, who was not involved in the study.
Given the degree of drinking identified in this population, Dr. Cao highlighted the importance of talking to patients about alcohol.
“Our findings highlight an opportunity for enhanced support and intervention concerning risky drinking behaviors” in oncology, Dr. Cao said. “Given the societal norms surrounding alcohol and the general lack of awareness of alcohol’s short- and long-term impact on cancer outcomes, gently educating patients/survivors about potential risks while understanding the cultural and societal contexts of drinking can make a difference.”
Dr. Islami agreed that oncologists should talk to their patients about alcohol, “especially those going through active treatment because alcohol may affect the treatment or may be associated with more complications of the treatment.”
“Many people now know that smoking causes cancer, but unfortunately, many people do not know about the association of alcohol with cancer,” he said.
Outside of an awareness gap, there are numerous risk factors for substance abuse among cancer survivors, Marleen Meyers, MD, director of the cancer survivorship program at NYU Langone Perlmutter Cancer Center, New York, explained.
Alcohol can help some cancer survivors dull feelings of isolation, fear, stress, and poor pain management that may accompany their diagnosis and treatment, said Dr. Meyers, who was not involved in the research. That is why “it is important for patients to be honest with their providers and for providers to ask about substance use in a nonjudgmental way.”
In these conversations, oncologists should educate patients about the safety risks associated with alcohol intake during or after treatment and that there is no established “safe” amount of alcohol. Incorporating a mental health screening and questions about a family history of substance abuse can also help identify patients “most at risk so providers can be proactive,” she said.
The study was supported by a grant from the NIH. Dr. Cao, Dr. Islami, and Dr. Meyers report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
An analysis of more than 15,000 adults with a cancer diagnosis revealed that nearly 80% were current drinkers. Among current drinkers, 13% consumed a moderate amount of alcohol in a typical day, while close to 40% engaged in hazardous drinking.
The numbers are “staggering,” Yin Cao, ScD, MPH, of Washington University in St. Louis, said in an interview. “Most concerning is that those on cancer treatment are engaged in a similar level of risky drinking.”
The study was published online in JAMA Network Open.
Drinking alcohol can increase a person’s risk for a variety of cancers, including oral and pharyngeal cancer as well as esophageal, colorectal, liver, and female breast cancers.
Consuming alcohol is also associated with numerous risks among people diagnosed with cancer. In the short term, alcohol consumption can worsen postsurgical outcomes as well as impair cognition and amplify cardiotoxicity in patients undergoing chemotherapy. In the long term, drinking alcohol can elevate a person’s risk of recurrence, secondary tumors, and mortality.
The American Society of Clinical Oncology recently issued a statement reinforcing the need to prioritize alcohol consumption as a key modifiable behavioral factor in the cancer control research agenda.
The current American Cancer Society guidelines indicate that it’s best to avoid or, at least, minimize alcohol consumption. Men should limit their intake to no more than two drinks per day and women should have no more than one drink per day.
Despite this data and guidelines, alcohol drinking patterns among cancer survivors in the United States remain poorly understood.
To explore further, the researchers identified 15,199 adult cancer survivors enrolled in the National Institutes of Health’s All of Us Research Program.
Overall, 78% of the cohort – more than 11,800 individuals – were current drinkers. In a typical day, 24% engaged in binge drinking – consuming six or more drinks on a single occasion – and 38% engaged in hazardous drinking. Using the Alcohol Use Disorders Identification Test–Consumption, the researchers classified hazardous drinking as scores of 4 or higher in men and 3 or higher in women.
Drinking patterns looked similar in the subset of 1,839 patients undergoing cancer treatment. In this group, 76% were current drinkers. Among current drinkers, 12% exceeded moderate drinking levels, 23% reported binge drinking, and 38% engaged in hazardous drinking. In this group, men, Hispanics, people diagnosed with cancer before age 18, and smokers were more likely to engage in risky drinking behaviors.
“We know that many people who are diagnosed with cancer continue to drink alcohol, but this study provides much more detailed information about that,” said Farhad Islami, MD, PhD, senior scientific director for cancer disparity research at the American Cancer Society, Atlanta, who was not involved in the study.
Given the degree of drinking identified in this population, Dr. Cao highlighted the importance of talking to patients about alcohol.
“Our findings highlight an opportunity for enhanced support and intervention concerning risky drinking behaviors” in oncology, Dr. Cao said. “Given the societal norms surrounding alcohol and the general lack of awareness of alcohol’s short- and long-term impact on cancer outcomes, gently educating patients/survivors about potential risks while understanding the cultural and societal contexts of drinking can make a difference.”
Dr. Islami agreed that oncologists should talk to their patients about alcohol, “especially those going through active treatment because alcohol may affect the treatment or may be associated with more complications of the treatment.”
“Many people now know that smoking causes cancer, but unfortunately, many people do not know about the association of alcohol with cancer,” he said.
Outside of an awareness gap, there are numerous risk factors for substance abuse among cancer survivors, Marleen Meyers, MD, director of the cancer survivorship program at NYU Langone Perlmutter Cancer Center, New York, explained.
Alcohol can help some cancer survivors dull feelings of isolation, fear, stress, and poor pain management that may accompany their diagnosis and treatment, said Dr. Meyers, who was not involved in the research. That is why “it is important for patients to be honest with their providers and for providers to ask about substance use in a nonjudgmental way.”
In these conversations, oncologists should educate patients about the safety risks associated with alcohol intake during or after treatment and that there is no established “safe” amount of alcohol. Incorporating a mental health screening and questions about a family history of substance abuse can also help identify patients “most at risk so providers can be proactive,” she said.
The study was supported by a grant from the NIH. Dr. Cao, Dr. Islami, and Dr. Meyers report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
An analysis of more than 15,000 adults with a cancer diagnosis revealed that nearly 80% were current drinkers. Among current drinkers, 13% consumed a moderate amount of alcohol in a typical day, while close to 40% engaged in hazardous drinking.
The numbers are “staggering,” Yin Cao, ScD, MPH, of Washington University in St. Louis, said in an interview. “Most concerning is that those on cancer treatment are engaged in a similar level of risky drinking.”
The study was published online in JAMA Network Open.
Drinking alcohol can increase a person’s risk for a variety of cancers, including oral and pharyngeal cancer as well as esophageal, colorectal, liver, and female breast cancers.
Consuming alcohol is also associated with numerous risks among people diagnosed with cancer. In the short term, alcohol consumption can worsen postsurgical outcomes as well as impair cognition and amplify cardiotoxicity in patients undergoing chemotherapy. In the long term, drinking alcohol can elevate a person’s risk of recurrence, secondary tumors, and mortality.
The American Society of Clinical Oncology recently issued a statement reinforcing the need to prioritize alcohol consumption as a key modifiable behavioral factor in the cancer control research agenda.
The current American Cancer Society guidelines indicate that it’s best to avoid or, at least, minimize alcohol consumption. Men should limit their intake to no more than two drinks per day and women should have no more than one drink per day.
Despite this data and guidelines, alcohol drinking patterns among cancer survivors in the United States remain poorly understood.
To explore further, the researchers identified 15,199 adult cancer survivors enrolled in the National Institutes of Health’s All of Us Research Program.
Overall, 78% of the cohort – more than 11,800 individuals – were current drinkers. In a typical day, 24% engaged in binge drinking – consuming six or more drinks on a single occasion – and 38% engaged in hazardous drinking. Using the Alcohol Use Disorders Identification Test–Consumption, the researchers classified hazardous drinking as scores of 4 or higher in men and 3 or higher in women.
Drinking patterns looked similar in the subset of 1,839 patients undergoing cancer treatment. In this group, 76% were current drinkers. Among current drinkers, 12% exceeded moderate drinking levels, 23% reported binge drinking, and 38% engaged in hazardous drinking. In this group, men, Hispanics, people diagnosed with cancer before age 18, and smokers were more likely to engage in risky drinking behaviors.
“We know that many people who are diagnosed with cancer continue to drink alcohol, but this study provides much more detailed information about that,” said Farhad Islami, MD, PhD, senior scientific director for cancer disparity research at the American Cancer Society, Atlanta, who was not involved in the study.
Given the degree of drinking identified in this population, Dr. Cao highlighted the importance of talking to patients about alcohol.
“Our findings highlight an opportunity for enhanced support and intervention concerning risky drinking behaviors” in oncology, Dr. Cao said. “Given the societal norms surrounding alcohol and the general lack of awareness of alcohol’s short- and long-term impact on cancer outcomes, gently educating patients/survivors about potential risks while understanding the cultural and societal contexts of drinking can make a difference.”
Dr. Islami agreed that oncologists should talk to their patients about alcohol, “especially those going through active treatment because alcohol may affect the treatment or may be associated with more complications of the treatment.”
“Many people now know that smoking causes cancer, but unfortunately, many people do not know about the association of alcohol with cancer,” he said.
Outside of an awareness gap, there are numerous risk factors for substance abuse among cancer survivors, Marleen Meyers, MD, director of the cancer survivorship program at NYU Langone Perlmutter Cancer Center, New York, explained.
Alcohol can help some cancer survivors dull feelings of isolation, fear, stress, and poor pain management that may accompany their diagnosis and treatment, said Dr. Meyers, who was not involved in the research. That is why “it is important for patients to be honest with their providers and for providers to ask about substance use in a nonjudgmental way.”
In these conversations, oncologists should educate patients about the safety risks associated with alcohol intake during or after treatment and that there is no established “safe” amount of alcohol. Incorporating a mental health screening and questions about a family history of substance abuse can also help identify patients “most at risk so providers can be proactive,” she said.
The study was supported by a grant from the NIH. Dr. Cao, Dr. Islami, and Dr. Meyers report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Mothers in medicine: What can we learn when worlds collide?
Across all industries, studies by the U.S. Department of Labor have shown that women, on average, earn 83.7 percent of what their male peers earn. While a lot has been written about the struggles women face in medicine, there have been decidedly fewer analyses that focus on women who choose to become mothers while working in medicine.
I’ve been privileged to work with medical students and residents for the last 8 years as the director of graduate and medical student mental health at Rowan-Virtua School of Osteopathic Medicine in Mt. Laurel, N.J. Often, the women I see as patients speak about their struggles with the elusive goal of “having it all.” While both men and women in medicine have difficulty maintaining a work-life balance, I’ve learned, both personally and professionally, that many women face a unique set of challenges.
No matter what their professional status, our society often views a woman as the default parent. For example, the teacher often calls the mothers first. The camp nurse calls me first, not my husband, when our child scrapes a knee. After-school play dates are arranged by the mothers, not fathers.
But mothers also bring to medicine a wealth of unique experiences, ideas, and viewpoints. They learn firsthand how to foster affect regulation and frustration tolerance in their kids and become efficient at managing the constant, conflicting tug of war of demands.
Some may argue that, over time, women end up earning significantly less than their male counterparts because they leave the workforce while on maternity leave, ultimately delaying their upward career progression. It’s likely a much more complex problem. Many of my patients believe that, in our male-dominated society (and workforce), women are punished for being aggressive or stating bold opinions, while men are rewarded for the same actions. While a man may sound forceful and in charge, a women will likely be thought of as brusque and unappreciative.
Outside of work, many women may have more on their plate. A 2020 Gallup poll of more than 3,000 heterosexual couples found that women are responsible for the majority of household chores. Women continue to handle more of the emotional labor within their families, regardless of income, age, or professional status. This is sometimes called the “Mental Load’ or “Second Shift.” As our society continues to view women as the default parent for childcare, medical issues, and overarching social and emotional tasks vital to raising happy, healthy children, the struggle a female medical professional feels is palpable.
Raising kids requires a parent to consistently dole out control, predictability, and reassurance for a child to thrive. Good limit and boundary setting leads to healthy development from a young age.
Psychiatric patients (and perhaps all patients) also require control, predictability, and reassurance from their doctor. The lessons learned in being a good mother can be directly applied in patient care, and vice versa. The cross-pollination of this relationship continues to grow more powerful as a woman’s children grow and her career matures.
Pediatrician and psychoanalyst Donald Winnicott’s idea of a “good enough” mother cannot be a one-size-fits-all approach. Women who self-select into the world of medicine often hold themselves to a higher standard than “good enough.” Acknowledging that the demands from both home and work will fluctuate is key to achieving success both personally and professionally, and lessons from home can and should be utilized to become a more effective physician. The notion of having it all, and the definition of success, must evolve over time.
Dr. Maymind is director of medical and graduate student mental health at Rowan-Virtua School of Osteopathic Medicine in Mt. Laurel, N.J. She has no relevant disclosures.
Across all industries, studies by the U.S. Department of Labor have shown that women, on average, earn 83.7 percent of what their male peers earn. While a lot has been written about the struggles women face in medicine, there have been decidedly fewer analyses that focus on women who choose to become mothers while working in medicine.
I’ve been privileged to work with medical students and residents for the last 8 years as the director of graduate and medical student mental health at Rowan-Virtua School of Osteopathic Medicine in Mt. Laurel, N.J. Often, the women I see as patients speak about their struggles with the elusive goal of “having it all.” While both men and women in medicine have difficulty maintaining a work-life balance, I’ve learned, both personally and professionally, that many women face a unique set of challenges.
No matter what their professional status, our society often views a woman as the default parent. For example, the teacher often calls the mothers first. The camp nurse calls me first, not my husband, when our child scrapes a knee. After-school play dates are arranged by the mothers, not fathers.
But mothers also bring to medicine a wealth of unique experiences, ideas, and viewpoints. They learn firsthand how to foster affect regulation and frustration tolerance in their kids and become efficient at managing the constant, conflicting tug of war of demands.
Some may argue that, over time, women end up earning significantly less than their male counterparts because they leave the workforce while on maternity leave, ultimately delaying their upward career progression. It’s likely a much more complex problem. Many of my patients believe that, in our male-dominated society (and workforce), women are punished for being aggressive or stating bold opinions, while men are rewarded for the same actions. While a man may sound forceful and in charge, a women will likely be thought of as brusque and unappreciative.
Outside of work, many women may have more on their plate. A 2020 Gallup poll of more than 3,000 heterosexual couples found that women are responsible for the majority of household chores. Women continue to handle more of the emotional labor within their families, regardless of income, age, or professional status. This is sometimes called the “Mental Load’ or “Second Shift.” As our society continues to view women as the default parent for childcare, medical issues, and overarching social and emotional tasks vital to raising happy, healthy children, the struggle a female medical professional feels is palpable.
Raising kids requires a parent to consistently dole out control, predictability, and reassurance for a child to thrive. Good limit and boundary setting leads to healthy development from a young age.
Psychiatric patients (and perhaps all patients) also require control, predictability, and reassurance from their doctor. The lessons learned in being a good mother can be directly applied in patient care, and vice versa. The cross-pollination of this relationship continues to grow more powerful as a woman’s children grow and her career matures.
Pediatrician and psychoanalyst Donald Winnicott’s idea of a “good enough” mother cannot be a one-size-fits-all approach. Women who self-select into the world of medicine often hold themselves to a higher standard than “good enough.” Acknowledging that the demands from both home and work will fluctuate is key to achieving success both personally and professionally, and lessons from home can and should be utilized to become a more effective physician. The notion of having it all, and the definition of success, must evolve over time.
Dr. Maymind is director of medical and graduate student mental health at Rowan-Virtua School of Osteopathic Medicine in Mt. Laurel, N.J. She has no relevant disclosures.
Across all industries, studies by the U.S. Department of Labor have shown that women, on average, earn 83.7 percent of what their male peers earn. While a lot has been written about the struggles women face in medicine, there have been decidedly fewer analyses that focus on women who choose to become mothers while working in medicine.
I’ve been privileged to work with medical students and residents for the last 8 years as the director of graduate and medical student mental health at Rowan-Virtua School of Osteopathic Medicine in Mt. Laurel, N.J. Often, the women I see as patients speak about their struggles with the elusive goal of “having it all.” While both men and women in medicine have difficulty maintaining a work-life balance, I’ve learned, both personally and professionally, that many women face a unique set of challenges.
No matter what their professional status, our society often views a woman as the default parent. For example, the teacher often calls the mothers first. The camp nurse calls me first, not my husband, when our child scrapes a knee. After-school play dates are arranged by the mothers, not fathers.
But mothers also bring to medicine a wealth of unique experiences, ideas, and viewpoints. They learn firsthand how to foster affect regulation and frustration tolerance in their kids and become efficient at managing the constant, conflicting tug of war of demands.
Some may argue that, over time, women end up earning significantly less than their male counterparts because they leave the workforce while on maternity leave, ultimately delaying their upward career progression. It’s likely a much more complex problem. Many of my patients believe that, in our male-dominated society (and workforce), women are punished for being aggressive or stating bold opinions, while men are rewarded for the same actions. While a man may sound forceful and in charge, a women will likely be thought of as brusque and unappreciative.
Outside of work, many women may have more on their plate. A 2020 Gallup poll of more than 3,000 heterosexual couples found that women are responsible for the majority of household chores. Women continue to handle more of the emotional labor within their families, regardless of income, age, or professional status. This is sometimes called the “Mental Load’ or “Second Shift.” As our society continues to view women as the default parent for childcare, medical issues, and overarching social and emotional tasks vital to raising happy, healthy children, the struggle a female medical professional feels is palpable.
Raising kids requires a parent to consistently dole out control, predictability, and reassurance for a child to thrive. Good limit and boundary setting leads to healthy development from a young age.
Psychiatric patients (and perhaps all patients) also require control, predictability, and reassurance from their doctor. The lessons learned in being a good mother can be directly applied in patient care, and vice versa. The cross-pollination of this relationship continues to grow more powerful as a woman’s children grow and her career matures.
Pediatrician and psychoanalyst Donald Winnicott’s idea of a “good enough” mother cannot be a one-size-fits-all approach. Women who self-select into the world of medicine often hold themselves to a higher standard than “good enough.” Acknowledging that the demands from both home and work will fluctuate is key to achieving success both personally and professionally, and lessons from home can and should be utilized to become a more effective physician. The notion of having it all, and the definition of success, must evolve over time.
Dr. Maymind is director of medical and graduate student mental health at Rowan-Virtua School of Osteopathic Medicine in Mt. Laurel, N.J. She has no relevant disclosures.
Dupilumab gains off-label uses as clinicians turn to drug for more indications
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The drug, marketed as Dupixent, is currently approved in the United States to treat atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis in adults. Dupilumab is also approved to treat eosinophilic esophagitis in patients aged 12 years and older and atopic dermatitis and asthma in some patients as young as age 6 months.
As the roster of approved and off-label indications grows, skin specialists said, pediatricians and other primary care providers should become familiar with the drug – given the increasing likelihood that their patients may be taking the medication.
The U.S. Food and Drug Administration first approved dupilumab in 2017 for eczema and has continued to add new treatment indications, the most recent being for prurigo nodularis, in 2022. Sanofi, which markets the drug with Regeneron, announced in April 2022 that some 430,000 patients worldwide were taking the drug – a figure it hoped to raise by 1.5 million by 2025.
A well-tolerated – if expensive – drug
Dupilumab, an interleukin-4 (IL-4) receptor alpha-antagonist biologic, blocks both IL-4 and IL-13 signaling, Marlys Fassett, MD, PhD, associate professor of dermatology at the University of California, San Francisco, told this news organization.
Dr. Fassett said she prescribes the drug off label for chronic idiopathic urticaria, including in older patients, and finds that the side effects in older patients are similar to those in younger people. The medication costs $36,000 per year, although some patients can get it more cheaply.
“Dupixent is a super-safe drug because it doesn’t immunosuppress any other part of the immune system, so you still have good antibacterial, antiviral, and antifungal immunity,” she added. “That makes perfect sense as a biological mechanism, and it’s been found safe in clinical trials.”
Case reports of potential adverse reactions to dupilumab have included ocular surface disease, lichen planus, and rash on the face and neck.
“We’re still learning about complications and are watching patients carefully,” said Marissa J. Perman, MD, section chief of dermatology at Children’s Hospital of Philadelphia.
Many people with atopic dermatitis also have other allergic conditions, such as contact dermatitis, asthma, prurigo nodularis, allergic rhinitis, and seasonal allergies. Each of these conditions has a pathway that depends on IL-4 receptors, Dr. Fassett said.
“It’s amazing how many conditions Dupixent improves. Sometimes we prescribe on-label Dupixent for atopic dermatitis, and inadvertently, the drug also improves that patient’s other, off-label conditions,” Dr. Fassett said. “I think that’s the best evidence that Dupixent works in these off-label cases.”
Lindsay C. Strowd, MD, associate professor of dermatology at Wake Forest University, Winston-Salem, N.C., said she uses off-label dupilumab to treat bullous pemphigoid and intense pruritus of unknown etiology.
“And several times I have treated drug reaction with eosinophilia and systemic symptoms, a rare adverse drug reaction that causes a rash and eosinophilia,” Dr. Strowd added.
Tissa Hata, MD, professor of medicine and clinical service chief at the University of California, San Diego, mainly treats elderly patients. She uses dupilumab to treat bullous pemphigoid and chronic pruritus. “There have been reports of using Dupixent to treat adult alopecia areata, chronic urticaria, localized scleroderma, and even keloids,” she told this news organization.
As a pediatric dermatologist, Dr. Perman treats children with atopic dermatitis as young as 3 months of age. She also uses dupilumab for alopecia areata, graft vs. host disease, and pruritus not otherwise specified.
Conjunctivitis and facial redness are two side effects Dr. Fassett sometimes sees with dupilumab. They occur similarly with all conditions and in all age groups. “We don’t know why they occur, and we don’t always know how to alleviate them,” she said. “So a small number of patients stop using Dupixent because they can’t tolerate those two side effects.
“We’re not worried about infection risk,” Dr. Fassett said. “Your patients may have heard of dupilumab as an immunosuppressant, but its immunosuppression is very focused. You can reassure them that they’re not at increased risk for viral or bacterial infections when they’re on this drug.”
“I don’t think there are any different safety signals to watch for with on-label vs. off-label Dupixent use,” Dr. Strowd added. “In general, the medicine is very safe.”
Dr. Hata said she is impressed with dupilumab’s safety in her elderly patients. All her patients older than 85 years who have taken the drug for bullous pemphigoid have tolerated it well, she said.
“Dupixent seems to be a safe alternative for elderly patients with pruritus because they often cannot tolerate sedating antihistamines due to the risk of falling,” Dr. Hata said. “And UV therapy may be difficult for elderly patients due to problems with transport.”
Although some of Dr. Hata’s elderly patients with atopic dermatitis have discontinued use of the drug after developing conjunctivitis, none taking the drug off label have discontinued it because of side effects, she noted.
“Dupixent manages the condition, but it is not a cure,” Dr. Fassett noted. “Based on the current data, we think it’s safe and effective to take long term, potentially for life.”
Making injections less bothersome
Dupilumab is injected subcutaneously from a single-dose prefilled syringe or a prefilled pen (syringe hidden in an opaque sheath), typically in the thigh, arm, abdomen, or buttocks. According to Sanofi and Regeneron, patients receive dupilumab injections every 2 to 4 weeks in doses based on their age and weight.
“The medication is somewhat viscous, so taking the syringe or pen out of the refrigerator ahead of time to warm it up can make the experience less painful,” Dr. Strowd advised. “For pediatric patients, I sometimes prescribe topical lidocaine applied 30 minutes before injection.”
Dr. Hata suggested icing the skin prior to injecting or distracting the patient by tapping a different area of the skin.
For her pediatric patients, Dr. Perman said she uses “lots of distraction, EMLA cream, and having one person hold the child while a second person injects.”
Clinic and pharmacy staff may show patients how to inject properly, Dr. Fassett added; and the product website provides injection tutorials.
Off-label dupixent can be expensive, difficult to obtain
The list price per injection, regardless of dose, is around $1,800. But according to the company’s website, most patients have health insurance or qualify for other assistance, so “very few patients pay the list price.”
Even so, “due to cost and insurance coverage hurdles, obtaining Dupixent for off-label use can be difficult,” Dr. Strowd said.
“In academic medicine, we can obtain drugs for our patients that community doctors may not get approval for,” Dr. Fassett added. “Community doctors can use information in the medical literature and in news articles to press insurance companies to spend money to provide their patients with Dupixent.”
The experts who commented have disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
.
The drug, marketed as Dupixent, is currently approved in the United States to treat atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis in adults. Dupilumab is also approved to treat eosinophilic esophagitis in patients aged 12 years and older and atopic dermatitis and asthma in some patients as young as age 6 months.
As the roster of approved and off-label indications grows, skin specialists said, pediatricians and other primary care providers should become familiar with the drug – given the increasing likelihood that their patients may be taking the medication.
The U.S. Food and Drug Administration first approved dupilumab in 2017 for eczema and has continued to add new treatment indications, the most recent being for prurigo nodularis, in 2022. Sanofi, which markets the drug with Regeneron, announced in April 2022 that some 430,000 patients worldwide were taking the drug – a figure it hoped to raise by 1.5 million by 2025.
A well-tolerated – if expensive – drug
Dupilumab, an interleukin-4 (IL-4) receptor alpha-antagonist biologic, blocks both IL-4 and IL-13 signaling, Marlys Fassett, MD, PhD, associate professor of dermatology at the University of California, San Francisco, told this news organization.
Dr. Fassett said she prescribes the drug off label for chronic idiopathic urticaria, including in older patients, and finds that the side effects in older patients are similar to those in younger people. The medication costs $36,000 per year, although some patients can get it more cheaply.
“Dupixent is a super-safe drug because it doesn’t immunosuppress any other part of the immune system, so you still have good antibacterial, antiviral, and antifungal immunity,” she added. “That makes perfect sense as a biological mechanism, and it’s been found safe in clinical trials.”
Case reports of potential adverse reactions to dupilumab have included ocular surface disease, lichen planus, and rash on the face and neck.
“We’re still learning about complications and are watching patients carefully,” said Marissa J. Perman, MD, section chief of dermatology at Children’s Hospital of Philadelphia.
Many people with atopic dermatitis also have other allergic conditions, such as contact dermatitis, asthma, prurigo nodularis, allergic rhinitis, and seasonal allergies. Each of these conditions has a pathway that depends on IL-4 receptors, Dr. Fassett said.
“It’s amazing how many conditions Dupixent improves. Sometimes we prescribe on-label Dupixent for atopic dermatitis, and inadvertently, the drug also improves that patient’s other, off-label conditions,” Dr. Fassett said. “I think that’s the best evidence that Dupixent works in these off-label cases.”
Lindsay C. Strowd, MD, associate professor of dermatology at Wake Forest University, Winston-Salem, N.C., said she uses off-label dupilumab to treat bullous pemphigoid and intense pruritus of unknown etiology.
“And several times I have treated drug reaction with eosinophilia and systemic symptoms, a rare adverse drug reaction that causes a rash and eosinophilia,” Dr. Strowd added.
Tissa Hata, MD, professor of medicine and clinical service chief at the University of California, San Diego, mainly treats elderly patients. She uses dupilumab to treat bullous pemphigoid and chronic pruritus. “There have been reports of using Dupixent to treat adult alopecia areata, chronic urticaria, localized scleroderma, and even keloids,” she told this news organization.
As a pediatric dermatologist, Dr. Perman treats children with atopic dermatitis as young as 3 months of age. She also uses dupilumab for alopecia areata, graft vs. host disease, and pruritus not otherwise specified.
Conjunctivitis and facial redness are two side effects Dr. Fassett sometimes sees with dupilumab. They occur similarly with all conditions and in all age groups. “We don’t know why they occur, and we don’t always know how to alleviate them,” she said. “So a small number of patients stop using Dupixent because they can’t tolerate those two side effects.
“We’re not worried about infection risk,” Dr. Fassett said. “Your patients may have heard of dupilumab as an immunosuppressant, but its immunosuppression is very focused. You can reassure them that they’re not at increased risk for viral or bacterial infections when they’re on this drug.”
“I don’t think there are any different safety signals to watch for with on-label vs. off-label Dupixent use,” Dr. Strowd added. “In general, the medicine is very safe.”
Dr. Hata said she is impressed with dupilumab’s safety in her elderly patients. All her patients older than 85 years who have taken the drug for bullous pemphigoid have tolerated it well, she said.
“Dupixent seems to be a safe alternative for elderly patients with pruritus because they often cannot tolerate sedating antihistamines due to the risk of falling,” Dr. Hata said. “And UV therapy may be difficult for elderly patients due to problems with transport.”
Although some of Dr. Hata’s elderly patients with atopic dermatitis have discontinued use of the drug after developing conjunctivitis, none taking the drug off label have discontinued it because of side effects, she noted.
“Dupixent manages the condition, but it is not a cure,” Dr. Fassett noted. “Based on the current data, we think it’s safe and effective to take long term, potentially for life.”
Making injections less bothersome
Dupilumab is injected subcutaneously from a single-dose prefilled syringe or a prefilled pen (syringe hidden in an opaque sheath), typically in the thigh, arm, abdomen, or buttocks. According to Sanofi and Regeneron, patients receive dupilumab injections every 2 to 4 weeks in doses based on their age and weight.
“The medication is somewhat viscous, so taking the syringe or pen out of the refrigerator ahead of time to warm it up can make the experience less painful,” Dr. Strowd advised. “For pediatric patients, I sometimes prescribe topical lidocaine applied 30 minutes before injection.”
Dr. Hata suggested icing the skin prior to injecting or distracting the patient by tapping a different area of the skin.
For her pediatric patients, Dr. Perman said she uses “lots of distraction, EMLA cream, and having one person hold the child while a second person injects.”
Clinic and pharmacy staff may show patients how to inject properly, Dr. Fassett added; and the product website provides injection tutorials.
Off-label dupixent can be expensive, difficult to obtain
The list price per injection, regardless of dose, is around $1,800. But according to the company’s website, most patients have health insurance or qualify for other assistance, so “very few patients pay the list price.”
Even so, “due to cost and insurance coverage hurdles, obtaining Dupixent for off-label use can be difficult,” Dr. Strowd said.
“In academic medicine, we can obtain drugs for our patients that community doctors may not get approval for,” Dr. Fassett added. “Community doctors can use information in the medical literature and in news articles to press insurance companies to spend money to provide their patients with Dupixent.”
The experts who commented have disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
.
The drug, marketed as Dupixent, is currently approved in the United States to treat atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis in adults. Dupilumab is also approved to treat eosinophilic esophagitis in patients aged 12 years and older and atopic dermatitis and asthma in some patients as young as age 6 months.
As the roster of approved and off-label indications grows, skin specialists said, pediatricians and other primary care providers should become familiar with the drug – given the increasing likelihood that their patients may be taking the medication.
The U.S. Food and Drug Administration first approved dupilumab in 2017 for eczema and has continued to add new treatment indications, the most recent being for prurigo nodularis, in 2022. Sanofi, which markets the drug with Regeneron, announced in April 2022 that some 430,000 patients worldwide were taking the drug – a figure it hoped to raise by 1.5 million by 2025.
A well-tolerated – if expensive – drug
Dupilumab, an interleukin-4 (IL-4) receptor alpha-antagonist biologic, blocks both IL-4 and IL-13 signaling, Marlys Fassett, MD, PhD, associate professor of dermatology at the University of California, San Francisco, told this news organization.
Dr. Fassett said she prescribes the drug off label for chronic idiopathic urticaria, including in older patients, and finds that the side effects in older patients are similar to those in younger people. The medication costs $36,000 per year, although some patients can get it more cheaply.
“Dupixent is a super-safe drug because it doesn’t immunosuppress any other part of the immune system, so you still have good antibacterial, antiviral, and antifungal immunity,” she added. “That makes perfect sense as a biological mechanism, and it’s been found safe in clinical trials.”
Case reports of potential adverse reactions to dupilumab have included ocular surface disease, lichen planus, and rash on the face and neck.
“We’re still learning about complications and are watching patients carefully,” said Marissa J. Perman, MD, section chief of dermatology at Children’s Hospital of Philadelphia.
Many people with atopic dermatitis also have other allergic conditions, such as contact dermatitis, asthma, prurigo nodularis, allergic rhinitis, and seasonal allergies. Each of these conditions has a pathway that depends on IL-4 receptors, Dr. Fassett said.
“It’s amazing how many conditions Dupixent improves. Sometimes we prescribe on-label Dupixent for atopic dermatitis, and inadvertently, the drug also improves that patient’s other, off-label conditions,” Dr. Fassett said. “I think that’s the best evidence that Dupixent works in these off-label cases.”
Lindsay C. Strowd, MD, associate professor of dermatology at Wake Forest University, Winston-Salem, N.C., said she uses off-label dupilumab to treat bullous pemphigoid and intense pruritus of unknown etiology.
“And several times I have treated drug reaction with eosinophilia and systemic symptoms, a rare adverse drug reaction that causes a rash and eosinophilia,” Dr. Strowd added.
Tissa Hata, MD, professor of medicine and clinical service chief at the University of California, San Diego, mainly treats elderly patients. She uses dupilumab to treat bullous pemphigoid and chronic pruritus. “There have been reports of using Dupixent to treat adult alopecia areata, chronic urticaria, localized scleroderma, and even keloids,” she told this news organization.
As a pediatric dermatologist, Dr. Perman treats children with atopic dermatitis as young as 3 months of age. She also uses dupilumab for alopecia areata, graft vs. host disease, and pruritus not otherwise specified.
Conjunctivitis and facial redness are two side effects Dr. Fassett sometimes sees with dupilumab. They occur similarly with all conditions and in all age groups. “We don’t know why they occur, and we don’t always know how to alleviate them,” she said. “So a small number of patients stop using Dupixent because they can’t tolerate those two side effects.
“We’re not worried about infection risk,” Dr. Fassett said. “Your patients may have heard of dupilumab as an immunosuppressant, but its immunosuppression is very focused. You can reassure them that they’re not at increased risk for viral or bacterial infections when they’re on this drug.”
“I don’t think there are any different safety signals to watch for with on-label vs. off-label Dupixent use,” Dr. Strowd added. “In general, the medicine is very safe.”
Dr. Hata said she is impressed with dupilumab’s safety in her elderly patients. All her patients older than 85 years who have taken the drug for bullous pemphigoid have tolerated it well, she said.
“Dupixent seems to be a safe alternative for elderly patients with pruritus because they often cannot tolerate sedating antihistamines due to the risk of falling,” Dr. Hata said. “And UV therapy may be difficult for elderly patients due to problems with transport.”
Although some of Dr. Hata’s elderly patients with atopic dermatitis have discontinued use of the drug after developing conjunctivitis, none taking the drug off label have discontinued it because of side effects, she noted.
“Dupixent manages the condition, but it is not a cure,” Dr. Fassett noted. “Based on the current data, we think it’s safe and effective to take long term, potentially for life.”
Making injections less bothersome
Dupilumab is injected subcutaneously from a single-dose prefilled syringe or a prefilled pen (syringe hidden in an opaque sheath), typically in the thigh, arm, abdomen, or buttocks. According to Sanofi and Regeneron, patients receive dupilumab injections every 2 to 4 weeks in doses based on their age and weight.
“The medication is somewhat viscous, so taking the syringe or pen out of the refrigerator ahead of time to warm it up can make the experience less painful,” Dr. Strowd advised. “For pediatric patients, I sometimes prescribe topical lidocaine applied 30 minutes before injection.”
Dr. Hata suggested icing the skin prior to injecting or distracting the patient by tapping a different area of the skin.
For her pediatric patients, Dr. Perman said she uses “lots of distraction, EMLA cream, and having one person hold the child while a second person injects.”
Clinic and pharmacy staff may show patients how to inject properly, Dr. Fassett added; and the product website provides injection tutorials.
Off-label dupixent can be expensive, difficult to obtain
The list price per injection, regardless of dose, is around $1,800. But according to the company’s website, most patients have health insurance or qualify for other assistance, so “very few patients pay the list price.”
Even so, “due to cost and insurance coverage hurdles, obtaining Dupixent for off-label use can be difficult,” Dr. Strowd said.
“In academic medicine, we can obtain drugs for our patients that community doctors may not get approval for,” Dr. Fassett added. “Community doctors can use information in the medical literature and in news articles to press insurance companies to spend money to provide their patients with Dupixent.”
The experts who commented have disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.