User login
Bringing you the latest news, research and reviews, exclusive interviews, podcasts, quizzes, and more.
div[contains(@class, 'header__large-screen')]
div[contains(@class, 'read-next-article')]
div[contains(@class, 'nav-primary')]
nav[contains(@class, 'nav-primary')]
section[contains(@class, 'footer-nav-section-wrapper')]
footer[@id='footer']
div[contains(@class, 'main-prefix')]
section[contains(@class, 'nav-hidden')]
div[contains(@class, 'ce-card-content')]
nav[contains(@class, 'nav-ce-stack')]
Clinic responsible for misdiagnosing newborn’s meningitis, must pay millions
according to a report in the Star Tribune, among other news outlets.
The story of the jury verdict begins in 2013, when the boy, Johnny Galligan, was just 8 days old.
Alarmed by the newborn’s crying, lack of appetite, and fever, his parents, Alina and Steve Galligan, brought him to Essentia-Health-Ashland Clinic, located in Memorial Medical Center, Ashland, Wisc. There, the baby was seen by Andrew D. Snider, MD, a family physician. Dr. Snider noted the baby’s extreme fussiness and irritability and was concerned that he was being overfed. Without ordering additional tests, the family physician sent the baby home but arranged for the Galligans to be visited by a county nurse the following day.
Her visit raised concerns, as court documents make clear. She contacted Dr. Snider’s office and explained that the baby needed to be seen immediately. After writing a script for reflux and constipation, Dr. Snider arranged for the baby to be taken to his office later that day.
Events proceeded rapidly from this point.
Following an x-ray, Johnny appeared lethargic and in respiratory distress. He was then taken down the hall to Memorial’s emergency department, where doctors suspected a critical bowel obstruction. Arrangements were made for him to be transported by helicopter to Essentia Health, Duluth, Minn. There, doctors saw that Johnny was acidotic and in respiratory failure. Once again, he was rerouted, this time to Children’s Hospital, Minneapolis, where physicians finally arrived at a definitive diagnosis: meningitis.
In 2020, the Galligans filed a medical malpractice claim against several parties, including Dr. Snider, Duluth Clinic (doing business as Essentia Health and Essentia Health–Ashland Clinic), and Memorial Hospital. In their suit, Johnny’s parents alleged that the collective failure to diagnose their son’s severe infection led directly to his permanent brain damage.
But a Bayfield County, Wisconsin, jury didn’t quite see things that way. After deliberating, it dismissed the claim against Dr. Snider and the other named defendants and found the staff of Duluth Clinic to be solely responsible for injuries to Johnny Galligan.
Duluth must pay $19 million to the Galligan family, of which the largest amount ($7,500,00) is to be directed to Johnny’s “future medical expenses and care needs.”
These expenses and costs are likely to be significant. Currently, at 10 years of age, Johnny can’t walk and is confined to a wheelchair. He has serious neurologic problems and is almost completely deaf and blind.
“He’s doing fairly well, which I attribute to his family providing care for him,” says the attorney who represented the Galligans. “They care for him 24/7. They take him swimming and on four-wheeler rides. He’s not bedridden. He has the best possible quality of life he could have, in my opinion.”
In a statement following the verdict, Essentia Health said that, while it felt “compassion for the family,” it stood by the care it had provided in 2013: “We are exploring our options regarding next steps and remain committed to delivering high-quality care to the patients and communities we are privileged to serve.”
ED physician found not liable for embolism, jury finds
A Missouri doctor accused of incorrectly treating a woman’s embolism has been found not liable for her death, reports a story in Missouri Lawyers Media.
The woman went to her local hospital’s ED complaining of pain and swelling in her leg. At the ED, an emergency physician examined her and discovered an extensive, visible thrombosis. No other symptoms were noted.
In the past, such a finding would have prompted immediate hospital admission. But the standard of care has evolved. Now, many doctors first prescribe enoxaparin sodium (Lovenox), an anticoagulant used to treat deep-vein thrombosis. This was the option chosen by the Missouri emergency physician to treat his patient. After administering a first dose of the drug, he wrote a script for additional doses; consulted with his patient’s primary care physician; and arranged for the patient to be seen by him, the ED physician, the following day.
At the drugstore, though, the woman became ill, and an emergency medical services crew was alerted. Despite its quick response, the woman died en route to the hospital. No autopsy was later performed, and it was generally presumed that she had died of a pulmonary embolism.
Following the woman’s death, her family sued the emergency physician, alleging that his failure to admit the woman to the hospital most likely delayed treatment that could have saved her life.
The defense pushed back, arguing that the ED physician had followed the standard of care. “Even if she [had] come into the ER with full-blown [pulmonary embolism],” says the attorney representing the emergency physician, “the first thing you do is give Lovenox. It is just one of those rare circumstances where you can do everything right, but the patient can still die.”
The trial jury agreed. After deliberating for more than an hour, it found that the emergency physician was not responsible for the patient’s death.
At press time, there was no word on whether the plaintiffs planned to appeal.
A version of this article first appeared on Medscape.com.
according to a report in the Star Tribune, among other news outlets.
The story of the jury verdict begins in 2013, when the boy, Johnny Galligan, was just 8 days old.
Alarmed by the newborn’s crying, lack of appetite, and fever, his parents, Alina and Steve Galligan, brought him to Essentia-Health-Ashland Clinic, located in Memorial Medical Center, Ashland, Wisc. There, the baby was seen by Andrew D. Snider, MD, a family physician. Dr. Snider noted the baby’s extreme fussiness and irritability and was concerned that he was being overfed. Without ordering additional tests, the family physician sent the baby home but arranged for the Galligans to be visited by a county nurse the following day.
Her visit raised concerns, as court documents make clear. She contacted Dr. Snider’s office and explained that the baby needed to be seen immediately. After writing a script for reflux and constipation, Dr. Snider arranged for the baby to be taken to his office later that day.
Events proceeded rapidly from this point.
Following an x-ray, Johnny appeared lethargic and in respiratory distress. He was then taken down the hall to Memorial’s emergency department, where doctors suspected a critical bowel obstruction. Arrangements were made for him to be transported by helicopter to Essentia Health, Duluth, Minn. There, doctors saw that Johnny was acidotic and in respiratory failure. Once again, he was rerouted, this time to Children’s Hospital, Minneapolis, where physicians finally arrived at a definitive diagnosis: meningitis.
In 2020, the Galligans filed a medical malpractice claim against several parties, including Dr. Snider, Duluth Clinic (doing business as Essentia Health and Essentia Health–Ashland Clinic), and Memorial Hospital. In their suit, Johnny’s parents alleged that the collective failure to diagnose their son’s severe infection led directly to his permanent brain damage.
But a Bayfield County, Wisconsin, jury didn’t quite see things that way. After deliberating, it dismissed the claim against Dr. Snider and the other named defendants and found the staff of Duluth Clinic to be solely responsible for injuries to Johnny Galligan.
Duluth must pay $19 million to the Galligan family, of which the largest amount ($7,500,00) is to be directed to Johnny’s “future medical expenses and care needs.”
These expenses and costs are likely to be significant. Currently, at 10 years of age, Johnny can’t walk and is confined to a wheelchair. He has serious neurologic problems and is almost completely deaf and blind.
“He’s doing fairly well, which I attribute to his family providing care for him,” says the attorney who represented the Galligans. “They care for him 24/7. They take him swimming and on four-wheeler rides. He’s not bedridden. He has the best possible quality of life he could have, in my opinion.”
In a statement following the verdict, Essentia Health said that, while it felt “compassion for the family,” it stood by the care it had provided in 2013: “We are exploring our options regarding next steps and remain committed to delivering high-quality care to the patients and communities we are privileged to serve.”
ED physician found not liable for embolism, jury finds
A Missouri doctor accused of incorrectly treating a woman’s embolism has been found not liable for her death, reports a story in Missouri Lawyers Media.
The woman went to her local hospital’s ED complaining of pain and swelling in her leg. At the ED, an emergency physician examined her and discovered an extensive, visible thrombosis. No other symptoms were noted.
In the past, such a finding would have prompted immediate hospital admission. But the standard of care has evolved. Now, many doctors first prescribe enoxaparin sodium (Lovenox), an anticoagulant used to treat deep-vein thrombosis. This was the option chosen by the Missouri emergency physician to treat his patient. After administering a first dose of the drug, he wrote a script for additional doses; consulted with his patient’s primary care physician; and arranged for the patient to be seen by him, the ED physician, the following day.
At the drugstore, though, the woman became ill, and an emergency medical services crew was alerted. Despite its quick response, the woman died en route to the hospital. No autopsy was later performed, and it was generally presumed that she had died of a pulmonary embolism.
Following the woman’s death, her family sued the emergency physician, alleging that his failure to admit the woman to the hospital most likely delayed treatment that could have saved her life.
The defense pushed back, arguing that the ED physician had followed the standard of care. “Even if she [had] come into the ER with full-blown [pulmonary embolism],” says the attorney representing the emergency physician, “the first thing you do is give Lovenox. It is just one of those rare circumstances where you can do everything right, but the patient can still die.”
The trial jury agreed. After deliberating for more than an hour, it found that the emergency physician was not responsible for the patient’s death.
At press time, there was no word on whether the plaintiffs planned to appeal.
A version of this article first appeared on Medscape.com.
according to a report in the Star Tribune, among other news outlets.
The story of the jury verdict begins in 2013, when the boy, Johnny Galligan, was just 8 days old.
Alarmed by the newborn’s crying, lack of appetite, and fever, his parents, Alina and Steve Galligan, brought him to Essentia-Health-Ashland Clinic, located in Memorial Medical Center, Ashland, Wisc. There, the baby was seen by Andrew D. Snider, MD, a family physician. Dr. Snider noted the baby’s extreme fussiness and irritability and was concerned that he was being overfed. Without ordering additional tests, the family physician sent the baby home but arranged for the Galligans to be visited by a county nurse the following day.
Her visit raised concerns, as court documents make clear. She contacted Dr. Snider’s office and explained that the baby needed to be seen immediately. After writing a script for reflux and constipation, Dr. Snider arranged for the baby to be taken to his office later that day.
Events proceeded rapidly from this point.
Following an x-ray, Johnny appeared lethargic and in respiratory distress. He was then taken down the hall to Memorial’s emergency department, where doctors suspected a critical bowel obstruction. Arrangements were made for him to be transported by helicopter to Essentia Health, Duluth, Minn. There, doctors saw that Johnny was acidotic and in respiratory failure. Once again, he was rerouted, this time to Children’s Hospital, Minneapolis, where physicians finally arrived at a definitive diagnosis: meningitis.
In 2020, the Galligans filed a medical malpractice claim against several parties, including Dr. Snider, Duluth Clinic (doing business as Essentia Health and Essentia Health–Ashland Clinic), and Memorial Hospital. In their suit, Johnny’s parents alleged that the collective failure to diagnose their son’s severe infection led directly to his permanent brain damage.
But a Bayfield County, Wisconsin, jury didn’t quite see things that way. After deliberating, it dismissed the claim against Dr. Snider and the other named defendants and found the staff of Duluth Clinic to be solely responsible for injuries to Johnny Galligan.
Duluth must pay $19 million to the Galligan family, of which the largest amount ($7,500,00) is to be directed to Johnny’s “future medical expenses and care needs.”
These expenses and costs are likely to be significant. Currently, at 10 years of age, Johnny can’t walk and is confined to a wheelchair. He has serious neurologic problems and is almost completely deaf and blind.
“He’s doing fairly well, which I attribute to his family providing care for him,” says the attorney who represented the Galligans. “They care for him 24/7. They take him swimming and on four-wheeler rides. He’s not bedridden. He has the best possible quality of life he could have, in my opinion.”
In a statement following the verdict, Essentia Health said that, while it felt “compassion for the family,” it stood by the care it had provided in 2013: “We are exploring our options regarding next steps and remain committed to delivering high-quality care to the patients and communities we are privileged to serve.”
ED physician found not liable for embolism, jury finds
A Missouri doctor accused of incorrectly treating a woman’s embolism has been found not liable for her death, reports a story in Missouri Lawyers Media.
The woman went to her local hospital’s ED complaining of pain and swelling in her leg. At the ED, an emergency physician examined her and discovered an extensive, visible thrombosis. No other symptoms were noted.
In the past, such a finding would have prompted immediate hospital admission. But the standard of care has evolved. Now, many doctors first prescribe enoxaparin sodium (Lovenox), an anticoagulant used to treat deep-vein thrombosis. This was the option chosen by the Missouri emergency physician to treat his patient. After administering a first dose of the drug, he wrote a script for additional doses; consulted with his patient’s primary care physician; and arranged for the patient to be seen by him, the ED physician, the following day.
At the drugstore, though, the woman became ill, and an emergency medical services crew was alerted. Despite its quick response, the woman died en route to the hospital. No autopsy was later performed, and it was generally presumed that she had died of a pulmonary embolism.
Following the woman’s death, her family sued the emergency physician, alleging that his failure to admit the woman to the hospital most likely delayed treatment that could have saved her life.
The defense pushed back, arguing that the ED physician had followed the standard of care. “Even if she [had] come into the ER with full-blown [pulmonary embolism],” says the attorney representing the emergency physician, “the first thing you do is give Lovenox. It is just one of those rare circumstances where you can do everything right, but the patient can still die.”
The trial jury agreed. After deliberating for more than an hour, it found that the emergency physician was not responsible for the patient’s death.
At press time, there was no word on whether the plaintiffs planned to appeal.
A version of this article first appeared on Medscape.com.
Most children with ADHD are not receiving treatment
Just more than one-third (34.8%) had received either treatment.
Researchers, led by Mark Olfson, MD, MPH, Elizabeth K. Dollard Professor of Psychiatry, Medicine and Law and professor of epidemiology at New York State Psychiatric Institute and Columbia University Department of Psychiatry, New York, also found that girls were much less likely to get medications.
In this cross-sectional sample taken from 11, 723 children in the Adolescent Brain and Cognitive Development Study, 1,206 children aged 9 and 10 years had parent-reported ADHD, and of those children, 15.7% of boys and 7% of girls were currently receiving ADHD medications. The parents reported the children met ADHD criteria according to the Diagnostic and Statistical Manual of Mental Disorders.
Findings were published online in JAMA Network Open.
Diagnoses have doubled but treatment numbers lag
Report authors noted that the percentage of U.S. children whose parents report their child has been diagnosed with ADHD has nearly doubled over 2 decades from 5.5% in 1999 to 9.8% in 2018. That has led to misperceptions among professionals and the public that the disorder is overdiagnosed and overtreated, the authors wrote.
However, they wrote, “a focus on the increasing numbers of children treated for ADHD does not give a sense of what fraction of children in the population with ADHD receive treatment.”
Higher uptake at lower income and education levels
Researchers also found that, contrary to popular belief, children with ADHD from families with lower educational levels and lower income were more likely than those with higher educational levels and higher incomes to have received outpatient mental health care.
Among children with ADHD whose parents did not have a high school education, 32.2% of children were receiving medications while among children of parents with a bachelor’s degree 11.5% received medications.
Among children from families with incomes of less than $25 000, 36.5% were receiving outpatient mental health care, compared with 20.1% of those from families with incomes of $75,000 or more.
“These patterns suggest that attitudinal rather than socioeconomic factors often impede the flow of children with ADHD into treatment,” they wrote.
Black children less likely to receive medications
The researchers found that substantially more White children (14.8% [104 of 759]) than Black children (9.4% [22 of 206]), received medication, a finding consistent with previous research.
“Population-based racial and ethnic gradients exist in prescriptions for stimulants and other controlled substances, with the highest rates in majority-White areas,” the authors wrote. “As a result of structural racism, Black parents’ perspectives might further influence ADHD management decisions through mistrust in clinicians and concerns over safety and efficacy of stimulants.”
“Physician efforts to recognize and manage their own implicit biases, together with patient-centered clinical approaches that promote shared decision-making,” might help narrow the treatment gap, the authors wrote. That includes talking with Black parents about their knowledge and beliefs concerning managing ADHD, they added.
Confirming diagnosis critical
The authors noted that not all children with parent-reported ADHD need treatment or would benefit from it.
Lenard Adler, MD, director of the adult ADHD program and professor of Psychiatry and Child and Adolescent Psychiatry at New York University Langone Health, who was not part of the current study, said this research emphasizes the urgency of clinical diagnosis.
Dr. Adler was part of a team of researchers that found similar low numbers for treatment among adults with ADHD.
The current results highlight that “we want to get the diagnosis correct so that people who receive a diagnosis actually have it and, if they do, that they have access to care. Because the consequences for not having treatment for ADHD are significant,” Dr. Adler said.
He urged physicians who diagnose ADHD to make follow-up part of the care plan or these treatment gaps will persist.
The authors wrote that the results suggest a need to increase availability for mental health services and better communicate symptoms among parents, teachers, and primary care providers.
The authors declare no relevant financial relationships. Dr. Adler has consulted with Supernus Pharmaceuticals and Otsuka Pharmaceuticals, has done research with Takeda, and has received royalty payments from NYU for licensing of ADHD training materials.
Just more than one-third (34.8%) had received either treatment.
Researchers, led by Mark Olfson, MD, MPH, Elizabeth K. Dollard Professor of Psychiatry, Medicine and Law and professor of epidemiology at New York State Psychiatric Institute and Columbia University Department of Psychiatry, New York, also found that girls were much less likely to get medications.
In this cross-sectional sample taken from 11, 723 children in the Adolescent Brain and Cognitive Development Study, 1,206 children aged 9 and 10 years had parent-reported ADHD, and of those children, 15.7% of boys and 7% of girls were currently receiving ADHD medications. The parents reported the children met ADHD criteria according to the Diagnostic and Statistical Manual of Mental Disorders.
Findings were published online in JAMA Network Open.
Diagnoses have doubled but treatment numbers lag
Report authors noted that the percentage of U.S. children whose parents report their child has been diagnosed with ADHD has nearly doubled over 2 decades from 5.5% in 1999 to 9.8% in 2018. That has led to misperceptions among professionals and the public that the disorder is overdiagnosed and overtreated, the authors wrote.
However, they wrote, “a focus on the increasing numbers of children treated for ADHD does not give a sense of what fraction of children in the population with ADHD receive treatment.”
Higher uptake at lower income and education levels
Researchers also found that, contrary to popular belief, children with ADHD from families with lower educational levels and lower income were more likely than those with higher educational levels and higher incomes to have received outpatient mental health care.
Among children with ADHD whose parents did not have a high school education, 32.2% of children were receiving medications while among children of parents with a bachelor’s degree 11.5% received medications.
Among children from families with incomes of less than $25 000, 36.5% were receiving outpatient mental health care, compared with 20.1% of those from families with incomes of $75,000 or more.
“These patterns suggest that attitudinal rather than socioeconomic factors often impede the flow of children with ADHD into treatment,” they wrote.
Black children less likely to receive medications
The researchers found that substantially more White children (14.8% [104 of 759]) than Black children (9.4% [22 of 206]), received medication, a finding consistent with previous research.
“Population-based racial and ethnic gradients exist in prescriptions for stimulants and other controlled substances, with the highest rates in majority-White areas,” the authors wrote. “As a result of structural racism, Black parents’ perspectives might further influence ADHD management decisions through mistrust in clinicians and concerns over safety and efficacy of stimulants.”
“Physician efforts to recognize and manage their own implicit biases, together with patient-centered clinical approaches that promote shared decision-making,” might help narrow the treatment gap, the authors wrote. That includes talking with Black parents about their knowledge and beliefs concerning managing ADHD, they added.
Confirming diagnosis critical
The authors noted that not all children with parent-reported ADHD need treatment or would benefit from it.
Lenard Adler, MD, director of the adult ADHD program and professor of Psychiatry and Child and Adolescent Psychiatry at New York University Langone Health, who was not part of the current study, said this research emphasizes the urgency of clinical diagnosis.
Dr. Adler was part of a team of researchers that found similar low numbers for treatment among adults with ADHD.
The current results highlight that “we want to get the diagnosis correct so that people who receive a diagnosis actually have it and, if they do, that they have access to care. Because the consequences for not having treatment for ADHD are significant,” Dr. Adler said.
He urged physicians who diagnose ADHD to make follow-up part of the care plan or these treatment gaps will persist.
The authors wrote that the results suggest a need to increase availability for mental health services and better communicate symptoms among parents, teachers, and primary care providers.
The authors declare no relevant financial relationships. Dr. Adler has consulted with Supernus Pharmaceuticals and Otsuka Pharmaceuticals, has done research with Takeda, and has received royalty payments from NYU for licensing of ADHD training materials.
Just more than one-third (34.8%) had received either treatment.
Researchers, led by Mark Olfson, MD, MPH, Elizabeth K. Dollard Professor of Psychiatry, Medicine and Law and professor of epidemiology at New York State Psychiatric Institute and Columbia University Department of Psychiatry, New York, also found that girls were much less likely to get medications.
In this cross-sectional sample taken from 11, 723 children in the Adolescent Brain and Cognitive Development Study, 1,206 children aged 9 and 10 years had parent-reported ADHD, and of those children, 15.7% of boys and 7% of girls were currently receiving ADHD medications. The parents reported the children met ADHD criteria according to the Diagnostic and Statistical Manual of Mental Disorders.
Findings were published online in JAMA Network Open.
Diagnoses have doubled but treatment numbers lag
Report authors noted that the percentage of U.S. children whose parents report their child has been diagnosed with ADHD has nearly doubled over 2 decades from 5.5% in 1999 to 9.8% in 2018. That has led to misperceptions among professionals and the public that the disorder is overdiagnosed and overtreated, the authors wrote.
However, they wrote, “a focus on the increasing numbers of children treated for ADHD does not give a sense of what fraction of children in the population with ADHD receive treatment.”
Higher uptake at lower income and education levels
Researchers also found that, contrary to popular belief, children with ADHD from families with lower educational levels and lower income were more likely than those with higher educational levels and higher incomes to have received outpatient mental health care.
Among children with ADHD whose parents did not have a high school education, 32.2% of children were receiving medications while among children of parents with a bachelor’s degree 11.5% received medications.
Among children from families with incomes of less than $25 000, 36.5% were receiving outpatient mental health care, compared with 20.1% of those from families with incomes of $75,000 or more.
“These patterns suggest that attitudinal rather than socioeconomic factors often impede the flow of children with ADHD into treatment,” they wrote.
Black children less likely to receive medications
The researchers found that substantially more White children (14.8% [104 of 759]) than Black children (9.4% [22 of 206]), received medication, a finding consistent with previous research.
“Population-based racial and ethnic gradients exist in prescriptions for stimulants and other controlled substances, with the highest rates in majority-White areas,” the authors wrote. “As a result of structural racism, Black parents’ perspectives might further influence ADHD management decisions through mistrust in clinicians and concerns over safety and efficacy of stimulants.”
“Physician efforts to recognize and manage their own implicit biases, together with patient-centered clinical approaches that promote shared decision-making,” might help narrow the treatment gap, the authors wrote. That includes talking with Black parents about their knowledge and beliefs concerning managing ADHD, they added.
Confirming diagnosis critical
The authors noted that not all children with parent-reported ADHD need treatment or would benefit from it.
Lenard Adler, MD, director of the adult ADHD program and professor of Psychiatry and Child and Adolescent Psychiatry at New York University Langone Health, who was not part of the current study, said this research emphasizes the urgency of clinical diagnosis.
Dr. Adler was part of a team of researchers that found similar low numbers for treatment among adults with ADHD.
The current results highlight that “we want to get the diagnosis correct so that people who receive a diagnosis actually have it and, if they do, that they have access to care. Because the consequences for not having treatment for ADHD are significant,” Dr. Adler said.
He urged physicians who diagnose ADHD to make follow-up part of the care plan or these treatment gaps will persist.
The authors wrote that the results suggest a need to increase availability for mental health services and better communicate symptoms among parents, teachers, and primary care providers.
The authors declare no relevant financial relationships. Dr. Adler has consulted with Supernus Pharmaceuticals and Otsuka Pharmaceuticals, has done research with Takeda, and has received royalty payments from NYU for licensing of ADHD training materials.
FROM JAMA NETWORK OPEN
Beware the hidden allergens in nutritional supplements
, Alison Ehrlich, MD, said at the annual meeting of the American Contact Dermatitis Society.
Allergens may be hidden in a range of supplement products, from colorings in vitamin C powders to some vitamins used in hair products and other products.
“In general, our patients do not tell us what supplements they are taking,” said Dr. Ehrlich, a dermatologist who practices in Washington, D.C. Antiaging, sleep, and weight loss/weight control supplements are among the most popular, she said.
Surveys have shown that many patients do not discuss supplement use with their health care providers, in part because they believe their providers would disapprove of supplement use, and patients are not educated about supplements, she said. “This is definitely an area that we should try to learn more about,” she added.
Current regulations regarding dietary supplements stem from the Dietary Supplement Health and Education Act of 1994, which defined dietary supplements as distinct from meals but regulated them as a category of food, not as medications. Dietary supplements can be vitamins, minerals, herbs, and extracts, Dr. Ehrlich said.
“There is not a lot of safety wrapped around how supplements come onto the market,” she explained. “It is not the manufacturer’s responsibility to test these products and make sure they are safe. When they get pulled off the market, it is because safety reports are getting back to the FDA.”
Consequently, a detailed history of supplement use is important, as it may reveal possible allergens as the cause of previously unidentified reactions, she said.
Dr. Ehrlich shared a case involving a patient who claimed to have had a reaction to a “Prevage-like” product that was labeled as a crepe repair cream. Listed among the product’s ingredients was idebenone, a synthetic version of the popular antioxidant known as Coenzyme Q.
Be wary of vitamins
Another potential source of allergy is vitamin C supplements, which became especially popular during the pandemic as people sought additional immune system support, Dr. Ehrlich noted. “What kind of vitamin C product our patients are taking is important,” she said. For example, some vitamin C powders contain coloring agents, such as carmine. Some also contain gelatin, which may cause an allergic reaction in individuals with alpha-gal syndrome, she added.
In general, water-soluble vitamins such as vitamins B1 to B9, B12, and C are more likely to cause an immediate reaction, Dr. Ehrlich said. Fat-soluble vitamins, such as vitamins A, D, E, and K, are more likely to cause a delayed reaction of allergic contact dermatitis.
Dr. Ehrlich described some unusual reactions to vitamins that have been reported, including a systemic allergy associated with vitamin B1 (thiamine), burning mouth syndrome associated with vitamin B3 (nicotinate), contact urticaria associated with vitamin B5 (panthenol), systemic allergy and generalized ACD associated with vitamin E (tocopherol), and erythema multiforme–like ACD associated with vitamin K1.
Notably, vitamin B5 has been associated with ACD as an ingredient in hair products, moisturizers, and wound care products, as well as B-complex vitamins and fortified foods, Dr. Ehrlich said.
Herbs and spices can act as allergens as well. Turmeric is a spice that has become a popular supplement ingredient, she said. Turmeric and curcumin (found in turmeric) can be used as a dye for its yellow color as well as a flavoring but has been associated with allergic reactions. Another popular herbal supplement, ginkgo biloba, has been marketed as a product that improves memory and cognition. It is available in pill form and in herbal teas.
“It’s really important to think about what herbal products our patients are taking, and not just in pill form,” Dr. Ehrlich said. “We need to expand our thoughts on what the herbs are in.”
Consider food additives as allergens
Food additives, in the form of colorants, preservatives, or flavoring agents, can cause allergic reactions, Dr. Ehrlich noted.
The question of whether food-additive contact sensitivity has a role in the occurrence of atopic dermatitis (AD) in children remains unclear, she said. However, a study published in 2020 found that 62% of children with AD had positive patch test reactions to at least one food-additive allergen, compared with 20% of children without AD. The additives responsible for the most reactions were azorubine (24.4%); formic acid (15.6%); and carmine, cochineal red, and amaranth (13.3% for each).
Common colorant culprits in allergic reactions include carmine, annatto, tartrazine, and spices (such as paprika and saffron), Dr. Ehrlich said. Carmine is used in meat to prevent photo-oxidation and to preserve a red color, and it has other uses as well, she said. Carmine has been associated with ACD, AD flares, and immediate hypersensitivity. Annatto is used in foods, including processed foods, butter, and cheese, to provide a yellow color. It is also found in some lipsticks and has been associated with urticaria and angioedema, she noted.
Food preservatives that have been associated with allergic reactions include butylated hydroxyanisole and sulfites, Dr. Ehrlich said. Sulfites are used to prevent food from turning brown, and it may be present in dried fruit, fruit juice, molasses, pickled foods, vinegar, and wine.
Reports of ACD in response to sodium metabisulfite have been increasing, she noted. Other sulfite reactions may occur with exposure to other products, such as cosmetics, body washes, and swimming pool water, she said.
Awareness of allergens in supplements is important “because the number of our patients taking supplements for different reasons is increasing” and allergens in supplements could account for flares, Dr. Ehrlich said. Clinicians should encourage patients to tell them what supplements they use. Clinicians should review the ingredients in these supplements with their patients to identify potential allergens that may be causing reactions, she advised.
Dr. Ehrlich has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, Alison Ehrlich, MD, said at the annual meeting of the American Contact Dermatitis Society.
Allergens may be hidden in a range of supplement products, from colorings in vitamin C powders to some vitamins used in hair products and other products.
“In general, our patients do not tell us what supplements they are taking,” said Dr. Ehrlich, a dermatologist who practices in Washington, D.C. Antiaging, sleep, and weight loss/weight control supplements are among the most popular, she said.
Surveys have shown that many patients do not discuss supplement use with their health care providers, in part because they believe their providers would disapprove of supplement use, and patients are not educated about supplements, she said. “This is definitely an area that we should try to learn more about,” she added.
Current regulations regarding dietary supplements stem from the Dietary Supplement Health and Education Act of 1994, which defined dietary supplements as distinct from meals but regulated them as a category of food, not as medications. Dietary supplements can be vitamins, minerals, herbs, and extracts, Dr. Ehrlich said.
“There is not a lot of safety wrapped around how supplements come onto the market,” she explained. “It is not the manufacturer’s responsibility to test these products and make sure they are safe. When they get pulled off the market, it is because safety reports are getting back to the FDA.”
Consequently, a detailed history of supplement use is important, as it may reveal possible allergens as the cause of previously unidentified reactions, she said.
Dr. Ehrlich shared a case involving a patient who claimed to have had a reaction to a “Prevage-like” product that was labeled as a crepe repair cream. Listed among the product’s ingredients was idebenone, a synthetic version of the popular antioxidant known as Coenzyme Q.
Be wary of vitamins
Another potential source of allergy is vitamin C supplements, which became especially popular during the pandemic as people sought additional immune system support, Dr. Ehrlich noted. “What kind of vitamin C product our patients are taking is important,” she said. For example, some vitamin C powders contain coloring agents, such as carmine. Some also contain gelatin, which may cause an allergic reaction in individuals with alpha-gal syndrome, she added.
In general, water-soluble vitamins such as vitamins B1 to B9, B12, and C are more likely to cause an immediate reaction, Dr. Ehrlich said. Fat-soluble vitamins, such as vitamins A, D, E, and K, are more likely to cause a delayed reaction of allergic contact dermatitis.
Dr. Ehrlich described some unusual reactions to vitamins that have been reported, including a systemic allergy associated with vitamin B1 (thiamine), burning mouth syndrome associated with vitamin B3 (nicotinate), contact urticaria associated with vitamin B5 (panthenol), systemic allergy and generalized ACD associated with vitamin E (tocopherol), and erythema multiforme–like ACD associated with vitamin K1.
Notably, vitamin B5 has been associated with ACD as an ingredient in hair products, moisturizers, and wound care products, as well as B-complex vitamins and fortified foods, Dr. Ehrlich said.
Herbs and spices can act as allergens as well. Turmeric is a spice that has become a popular supplement ingredient, she said. Turmeric and curcumin (found in turmeric) can be used as a dye for its yellow color as well as a flavoring but has been associated with allergic reactions. Another popular herbal supplement, ginkgo biloba, has been marketed as a product that improves memory and cognition. It is available in pill form and in herbal teas.
“It’s really important to think about what herbal products our patients are taking, and not just in pill form,” Dr. Ehrlich said. “We need to expand our thoughts on what the herbs are in.”
Consider food additives as allergens
Food additives, in the form of colorants, preservatives, or flavoring agents, can cause allergic reactions, Dr. Ehrlich noted.
The question of whether food-additive contact sensitivity has a role in the occurrence of atopic dermatitis (AD) in children remains unclear, she said. However, a study published in 2020 found that 62% of children with AD had positive patch test reactions to at least one food-additive allergen, compared with 20% of children without AD. The additives responsible for the most reactions were azorubine (24.4%); formic acid (15.6%); and carmine, cochineal red, and amaranth (13.3% for each).
Common colorant culprits in allergic reactions include carmine, annatto, tartrazine, and spices (such as paprika and saffron), Dr. Ehrlich said. Carmine is used in meat to prevent photo-oxidation and to preserve a red color, and it has other uses as well, she said. Carmine has been associated with ACD, AD flares, and immediate hypersensitivity. Annatto is used in foods, including processed foods, butter, and cheese, to provide a yellow color. It is also found in some lipsticks and has been associated with urticaria and angioedema, she noted.
Food preservatives that have been associated with allergic reactions include butylated hydroxyanisole and sulfites, Dr. Ehrlich said. Sulfites are used to prevent food from turning brown, and it may be present in dried fruit, fruit juice, molasses, pickled foods, vinegar, and wine.
Reports of ACD in response to sodium metabisulfite have been increasing, she noted. Other sulfite reactions may occur with exposure to other products, such as cosmetics, body washes, and swimming pool water, she said.
Awareness of allergens in supplements is important “because the number of our patients taking supplements for different reasons is increasing” and allergens in supplements could account for flares, Dr. Ehrlich said. Clinicians should encourage patients to tell them what supplements they use. Clinicians should review the ingredients in these supplements with their patients to identify potential allergens that may be causing reactions, she advised.
Dr. Ehrlich has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, Alison Ehrlich, MD, said at the annual meeting of the American Contact Dermatitis Society.
Allergens may be hidden in a range of supplement products, from colorings in vitamin C powders to some vitamins used in hair products and other products.
“In general, our patients do not tell us what supplements they are taking,” said Dr. Ehrlich, a dermatologist who practices in Washington, D.C. Antiaging, sleep, and weight loss/weight control supplements are among the most popular, she said.
Surveys have shown that many patients do not discuss supplement use with their health care providers, in part because they believe their providers would disapprove of supplement use, and patients are not educated about supplements, she said. “This is definitely an area that we should try to learn more about,” she added.
Current regulations regarding dietary supplements stem from the Dietary Supplement Health and Education Act of 1994, which defined dietary supplements as distinct from meals but regulated them as a category of food, not as medications. Dietary supplements can be vitamins, minerals, herbs, and extracts, Dr. Ehrlich said.
“There is not a lot of safety wrapped around how supplements come onto the market,” she explained. “It is not the manufacturer’s responsibility to test these products and make sure they are safe. When they get pulled off the market, it is because safety reports are getting back to the FDA.”
Consequently, a detailed history of supplement use is important, as it may reveal possible allergens as the cause of previously unidentified reactions, she said.
Dr. Ehrlich shared a case involving a patient who claimed to have had a reaction to a “Prevage-like” product that was labeled as a crepe repair cream. Listed among the product’s ingredients was idebenone, a synthetic version of the popular antioxidant known as Coenzyme Q.
Be wary of vitamins
Another potential source of allergy is vitamin C supplements, which became especially popular during the pandemic as people sought additional immune system support, Dr. Ehrlich noted. “What kind of vitamin C product our patients are taking is important,” she said. For example, some vitamin C powders contain coloring agents, such as carmine. Some also contain gelatin, which may cause an allergic reaction in individuals with alpha-gal syndrome, she added.
In general, water-soluble vitamins such as vitamins B1 to B9, B12, and C are more likely to cause an immediate reaction, Dr. Ehrlich said. Fat-soluble vitamins, such as vitamins A, D, E, and K, are more likely to cause a delayed reaction of allergic contact dermatitis.
Dr. Ehrlich described some unusual reactions to vitamins that have been reported, including a systemic allergy associated with vitamin B1 (thiamine), burning mouth syndrome associated with vitamin B3 (nicotinate), contact urticaria associated with vitamin B5 (panthenol), systemic allergy and generalized ACD associated with vitamin E (tocopherol), and erythema multiforme–like ACD associated with vitamin K1.
Notably, vitamin B5 has been associated with ACD as an ingredient in hair products, moisturizers, and wound care products, as well as B-complex vitamins and fortified foods, Dr. Ehrlich said.
Herbs and spices can act as allergens as well. Turmeric is a spice that has become a popular supplement ingredient, she said. Turmeric and curcumin (found in turmeric) can be used as a dye for its yellow color as well as a flavoring but has been associated with allergic reactions. Another popular herbal supplement, ginkgo biloba, has been marketed as a product that improves memory and cognition. It is available in pill form and in herbal teas.
“It’s really important to think about what herbal products our patients are taking, and not just in pill form,” Dr. Ehrlich said. “We need to expand our thoughts on what the herbs are in.”
Consider food additives as allergens
Food additives, in the form of colorants, preservatives, or flavoring agents, can cause allergic reactions, Dr. Ehrlich noted.
The question of whether food-additive contact sensitivity has a role in the occurrence of atopic dermatitis (AD) in children remains unclear, she said. However, a study published in 2020 found that 62% of children with AD had positive patch test reactions to at least one food-additive allergen, compared with 20% of children without AD. The additives responsible for the most reactions were azorubine (24.4%); formic acid (15.6%); and carmine, cochineal red, and amaranth (13.3% for each).
Common colorant culprits in allergic reactions include carmine, annatto, tartrazine, and spices (such as paprika and saffron), Dr. Ehrlich said. Carmine is used in meat to prevent photo-oxidation and to preserve a red color, and it has other uses as well, she said. Carmine has been associated with ACD, AD flares, and immediate hypersensitivity. Annatto is used in foods, including processed foods, butter, and cheese, to provide a yellow color. It is also found in some lipsticks and has been associated with urticaria and angioedema, she noted.
Food preservatives that have been associated with allergic reactions include butylated hydroxyanisole and sulfites, Dr. Ehrlich said. Sulfites are used to prevent food from turning brown, and it may be present in dried fruit, fruit juice, molasses, pickled foods, vinegar, and wine.
Reports of ACD in response to sodium metabisulfite have been increasing, she noted. Other sulfite reactions may occur with exposure to other products, such as cosmetics, body washes, and swimming pool water, she said.
Awareness of allergens in supplements is important “because the number of our patients taking supplements for different reasons is increasing” and allergens in supplements could account for flares, Dr. Ehrlich said. Clinicians should encourage patients to tell them what supplements they use. Clinicians should review the ingredients in these supplements with their patients to identify potential allergens that may be causing reactions, she advised.
Dr. Ehrlich has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ACDS 2023
Study shows higher obesity-related cancer mortality in areas with more fast food
based on data from a new cross-sectional study of more than 3,000 communities.
Although increased healthy eating has been associated with reduced risk of obesity and with reduced cancer incidence and mortality, access to healthier eating remains a challenge in communities with less access to grocery stores and healthy food options (food deserts) and/or easy access to convenience stores and fast food (food swamps), Malcolm Seth Bevel, PhD, of the Medical College of Georgia, Augusta, and colleagues, wrote in their paper, published in JAMA Oncology.
In addition, data on the association between food deserts and swamps and obesity-related cancer mortality are limited, they said.
“We felt that the study was important given the fact that obesity is an epidemic in the United States, and multiple factors contribute to obesity, especially adverse food environments,” Dr. Bevel said in an interview. “Also, I lived in these areas my whole life, and saw how it affected underserved populations. There was a story that needed to be told, so we’re telling it,” he said in an interview.
In a study, the researchers analyzed food access and cancer mortality data from 3,038 counties across the United States. The food access data came from the U.S. Department of Agriculture Food Environment Atlas (FEA) for the years 2012, 2014, 2015, 2017, and 2020. Data on obesity-related cancer mortality came from the Centers for Disease Control and Prevention for the years from 2010 to 2020.
Food desert scores were calculated through data from the FEA, and food swamp scores were based on the ratio of fast-food restaurants and convenience stores to grocery stores and farmers markets in a modification of the Retail Food Environment Index score.
The researchers used an age-adjusted, multiple regression model to determine the association between food desert and food swamp scores and obesity-related cancer mortality rates. Higher food swamp and food desert scores (defined as 20.0 to 58.0 or higher) were used to classify counties as having fewer healthy food resources. The primary outcome was obesity-related cancer mortality, defined as high or low (71.8 or higher per 100,000 individuals and less than 71.8 per 100,000 individuals, respectively).
Overall, high rates of obesity-related cancer mortality were 77% more likely in the counties that met the criteria for high food swamp scores (adjusted odds ratio 1.77). In addition, researchers found a positive dose-response relationship among three levels of both food desert scores and food swamp scores and obesity-related cancer mortality.
A total of 758 counties had obesity-related cancer mortality rates in the highest quartile. Compared to counties with low rates of obesity-related cancer mortality, counties with high rates of obesity-related cancer mortality also had a higher percentage of non-Hispanic Black residents (3.26% vs. 1.77%), higher percentage of adults older than 65 years (15.71% vs. 15.40%), higher rates of adult obesity (33.0% vs. 32.10%), and higher rates of adult diabetes (12.50% vs. 10.70%).
Possible explanations for the results include the lack of interest in grocery stores in neighborhoods with a population with a lower socioeconomic status, which can create a food desert, the researchers wrote in their discussion. “Coupled with the increasing growth rate of fast-food restaurants in recent years and the intentional advertisement of unhealthy foods in urban neighborhoods with [people of lower income], the food desert may transform into a food swamp,” they said.
The findings were limited by several factors including the study design, which did not allow for showing a causal association of food deserts and food swamps with obesity-related cancer mortality, the researchers noted. Other limitations included the use of groups rather than individuals, the potential misclassification of food stores, and the use of county-level data on race, ethnicity, and income, they wrote.
The results indicate that “food swamps appear to be a growing epidemic across the U.S., likely because of systemic issues, and should draw concern and conversation from local and state officials,” the researchers concluded.
Community-level investments can benefit individual health
Dr. Bevel said he was not surprised by the findings, as he has seen firsthand the lack of healthy food options and growth of unhealthy food options, especially for certain populations in certain communities. “Typically, these are people who have lower socioeconomic status, primarily non-Hispanic Black or African American or Hispanic American,” he said “I have watched people have to choose between getting fruits/vegetables versus their medications or running to fast food places to feed their families. What is truly surprising is that we’re not talking about people’s lived environment enough for my taste,” he said.
“I hope that our data and results can inform local and state policymakers to truly invest in all communities, such as funding for community gardens, and realize that adverse food environments, including the barriers in navigating these environments, have significant consequences on real people,” said Dr. Bevel. “Also, I hope that the results can help clinicians realize that a patient’s lived environment can truly affect their obesity and/or obesity-related cancer status; being cognizant of that is the first step in holistic, comprehensive care,” he said.
“One role that oncologists might be able to play in improving patients’ access to healthier food is to create and/or implement healthy lifestyle programs with gardening components to combat the poorest food environments that their patients likely reside in,” said Dr. Bevel. Clinicians also could consider the innovative approach of “food prescriptions” to help reduce the effects of deprived, built environments, he noted.
Looking ahead, next steps for research include determining the severity of association between food swamps and obesity-related cancer by varying factors such as cancer type, and examining any potential racial disparities between people living in these environments and obesity-related cancer, Dr. Bevel added.
Data provide foundation for multilevel interventions
The current study findings “raise a clarion call to elevate the discussion on food availability and access to ensure an equitable emphasis on both the importance of lifestyle factors and the upstream structural, economic, and environmental contexts that shape these behaviors at the individual level,” Karriem S. Watson, DHSc, MS, MPH, of the National Institutes of Health, Bethesda, Md., and Angela Odoms-Young, PhD, of Cornell University, Ithaca, N.Y., wrote in an accompanying editorial.
The findings provide a foundation for studies of obesity-related cancer outcomes that take the community environment into consideration, they added.
The causes of both obesity and cancer are complex, and the study findings suggest that the links between unhealthy food environments and obesity-related cancer may go beyond dietary consumption alone and extend to social and psychological factors, the editorialists noted.
“Whether dealing with the lack of access to healthy foods or an overabundance of unhealthy food, there is a critical need to develop additional research that explores the associations between obesity-related cancer mortality and food inequities,” they concluded.
The study received no outside funding. The researchers and the editorialists had no financial conflicts to disclose.
based on data from a new cross-sectional study of more than 3,000 communities.
Although increased healthy eating has been associated with reduced risk of obesity and with reduced cancer incidence and mortality, access to healthier eating remains a challenge in communities with less access to grocery stores and healthy food options (food deserts) and/or easy access to convenience stores and fast food (food swamps), Malcolm Seth Bevel, PhD, of the Medical College of Georgia, Augusta, and colleagues, wrote in their paper, published in JAMA Oncology.
In addition, data on the association between food deserts and swamps and obesity-related cancer mortality are limited, they said.
“We felt that the study was important given the fact that obesity is an epidemic in the United States, and multiple factors contribute to obesity, especially adverse food environments,” Dr. Bevel said in an interview. “Also, I lived in these areas my whole life, and saw how it affected underserved populations. There was a story that needed to be told, so we’re telling it,” he said in an interview.
In a study, the researchers analyzed food access and cancer mortality data from 3,038 counties across the United States. The food access data came from the U.S. Department of Agriculture Food Environment Atlas (FEA) for the years 2012, 2014, 2015, 2017, and 2020. Data on obesity-related cancer mortality came from the Centers for Disease Control and Prevention for the years from 2010 to 2020.
Food desert scores were calculated through data from the FEA, and food swamp scores were based on the ratio of fast-food restaurants and convenience stores to grocery stores and farmers markets in a modification of the Retail Food Environment Index score.
The researchers used an age-adjusted, multiple regression model to determine the association between food desert and food swamp scores and obesity-related cancer mortality rates. Higher food swamp and food desert scores (defined as 20.0 to 58.0 or higher) were used to classify counties as having fewer healthy food resources. The primary outcome was obesity-related cancer mortality, defined as high or low (71.8 or higher per 100,000 individuals and less than 71.8 per 100,000 individuals, respectively).
Overall, high rates of obesity-related cancer mortality were 77% more likely in the counties that met the criteria for high food swamp scores (adjusted odds ratio 1.77). In addition, researchers found a positive dose-response relationship among three levels of both food desert scores and food swamp scores and obesity-related cancer mortality.
A total of 758 counties had obesity-related cancer mortality rates in the highest quartile. Compared to counties with low rates of obesity-related cancer mortality, counties with high rates of obesity-related cancer mortality also had a higher percentage of non-Hispanic Black residents (3.26% vs. 1.77%), higher percentage of adults older than 65 years (15.71% vs. 15.40%), higher rates of adult obesity (33.0% vs. 32.10%), and higher rates of adult diabetes (12.50% vs. 10.70%).
Possible explanations for the results include the lack of interest in grocery stores in neighborhoods with a population with a lower socioeconomic status, which can create a food desert, the researchers wrote in their discussion. “Coupled with the increasing growth rate of fast-food restaurants in recent years and the intentional advertisement of unhealthy foods in urban neighborhoods with [people of lower income], the food desert may transform into a food swamp,” they said.
The findings were limited by several factors including the study design, which did not allow for showing a causal association of food deserts and food swamps with obesity-related cancer mortality, the researchers noted. Other limitations included the use of groups rather than individuals, the potential misclassification of food stores, and the use of county-level data on race, ethnicity, and income, they wrote.
The results indicate that “food swamps appear to be a growing epidemic across the U.S., likely because of systemic issues, and should draw concern and conversation from local and state officials,” the researchers concluded.
Community-level investments can benefit individual health
Dr. Bevel said he was not surprised by the findings, as he has seen firsthand the lack of healthy food options and growth of unhealthy food options, especially for certain populations in certain communities. “Typically, these are people who have lower socioeconomic status, primarily non-Hispanic Black or African American or Hispanic American,” he said “I have watched people have to choose between getting fruits/vegetables versus their medications or running to fast food places to feed their families. What is truly surprising is that we’re not talking about people’s lived environment enough for my taste,” he said.
“I hope that our data and results can inform local and state policymakers to truly invest in all communities, such as funding for community gardens, and realize that adverse food environments, including the barriers in navigating these environments, have significant consequences on real people,” said Dr. Bevel. “Also, I hope that the results can help clinicians realize that a patient’s lived environment can truly affect their obesity and/or obesity-related cancer status; being cognizant of that is the first step in holistic, comprehensive care,” he said.
“One role that oncologists might be able to play in improving patients’ access to healthier food is to create and/or implement healthy lifestyle programs with gardening components to combat the poorest food environments that their patients likely reside in,” said Dr. Bevel. Clinicians also could consider the innovative approach of “food prescriptions” to help reduce the effects of deprived, built environments, he noted.
Looking ahead, next steps for research include determining the severity of association between food swamps and obesity-related cancer by varying factors such as cancer type, and examining any potential racial disparities between people living in these environments and obesity-related cancer, Dr. Bevel added.
Data provide foundation for multilevel interventions
The current study findings “raise a clarion call to elevate the discussion on food availability and access to ensure an equitable emphasis on both the importance of lifestyle factors and the upstream structural, economic, and environmental contexts that shape these behaviors at the individual level,” Karriem S. Watson, DHSc, MS, MPH, of the National Institutes of Health, Bethesda, Md., and Angela Odoms-Young, PhD, of Cornell University, Ithaca, N.Y., wrote in an accompanying editorial.
The findings provide a foundation for studies of obesity-related cancer outcomes that take the community environment into consideration, they added.
The causes of both obesity and cancer are complex, and the study findings suggest that the links between unhealthy food environments and obesity-related cancer may go beyond dietary consumption alone and extend to social and psychological factors, the editorialists noted.
“Whether dealing with the lack of access to healthy foods or an overabundance of unhealthy food, there is a critical need to develop additional research that explores the associations between obesity-related cancer mortality and food inequities,” they concluded.
The study received no outside funding. The researchers and the editorialists had no financial conflicts to disclose.
based on data from a new cross-sectional study of more than 3,000 communities.
Although increased healthy eating has been associated with reduced risk of obesity and with reduced cancer incidence and mortality, access to healthier eating remains a challenge in communities with less access to grocery stores and healthy food options (food deserts) and/or easy access to convenience stores and fast food (food swamps), Malcolm Seth Bevel, PhD, of the Medical College of Georgia, Augusta, and colleagues, wrote in their paper, published in JAMA Oncology.
In addition, data on the association between food deserts and swamps and obesity-related cancer mortality are limited, they said.
“We felt that the study was important given the fact that obesity is an epidemic in the United States, and multiple factors contribute to obesity, especially adverse food environments,” Dr. Bevel said in an interview. “Also, I lived in these areas my whole life, and saw how it affected underserved populations. There was a story that needed to be told, so we’re telling it,” he said in an interview.
In a study, the researchers analyzed food access and cancer mortality data from 3,038 counties across the United States. The food access data came from the U.S. Department of Agriculture Food Environment Atlas (FEA) for the years 2012, 2014, 2015, 2017, and 2020. Data on obesity-related cancer mortality came from the Centers for Disease Control and Prevention for the years from 2010 to 2020.
Food desert scores were calculated through data from the FEA, and food swamp scores were based on the ratio of fast-food restaurants and convenience stores to grocery stores and farmers markets in a modification of the Retail Food Environment Index score.
The researchers used an age-adjusted, multiple regression model to determine the association between food desert and food swamp scores and obesity-related cancer mortality rates. Higher food swamp and food desert scores (defined as 20.0 to 58.0 or higher) were used to classify counties as having fewer healthy food resources. The primary outcome was obesity-related cancer mortality, defined as high or low (71.8 or higher per 100,000 individuals and less than 71.8 per 100,000 individuals, respectively).
Overall, high rates of obesity-related cancer mortality were 77% more likely in the counties that met the criteria for high food swamp scores (adjusted odds ratio 1.77). In addition, researchers found a positive dose-response relationship among three levels of both food desert scores and food swamp scores and obesity-related cancer mortality.
A total of 758 counties had obesity-related cancer mortality rates in the highest quartile. Compared to counties with low rates of obesity-related cancer mortality, counties with high rates of obesity-related cancer mortality also had a higher percentage of non-Hispanic Black residents (3.26% vs. 1.77%), higher percentage of adults older than 65 years (15.71% vs. 15.40%), higher rates of adult obesity (33.0% vs. 32.10%), and higher rates of adult diabetes (12.50% vs. 10.70%).
Possible explanations for the results include the lack of interest in grocery stores in neighborhoods with a population with a lower socioeconomic status, which can create a food desert, the researchers wrote in their discussion. “Coupled with the increasing growth rate of fast-food restaurants in recent years and the intentional advertisement of unhealthy foods in urban neighborhoods with [people of lower income], the food desert may transform into a food swamp,” they said.
The findings were limited by several factors including the study design, which did not allow for showing a causal association of food deserts and food swamps with obesity-related cancer mortality, the researchers noted. Other limitations included the use of groups rather than individuals, the potential misclassification of food stores, and the use of county-level data on race, ethnicity, and income, they wrote.
The results indicate that “food swamps appear to be a growing epidemic across the U.S., likely because of systemic issues, and should draw concern and conversation from local and state officials,” the researchers concluded.
Community-level investments can benefit individual health
Dr. Bevel said he was not surprised by the findings, as he has seen firsthand the lack of healthy food options and growth of unhealthy food options, especially for certain populations in certain communities. “Typically, these are people who have lower socioeconomic status, primarily non-Hispanic Black or African American or Hispanic American,” he said “I have watched people have to choose between getting fruits/vegetables versus their medications or running to fast food places to feed their families. What is truly surprising is that we’re not talking about people’s lived environment enough for my taste,” he said.
“I hope that our data and results can inform local and state policymakers to truly invest in all communities, such as funding for community gardens, and realize that adverse food environments, including the barriers in navigating these environments, have significant consequences on real people,” said Dr. Bevel. “Also, I hope that the results can help clinicians realize that a patient’s lived environment can truly affect their obesity and/or obesity-related cancer status; being cognizant of that is the first step in holistic, comprehensive care,” he said.
“One role that oncologists might be able to play in improving patients’ access to healthier food is to create and/or implement healthy lifestyle programs with gardening components to combat the poorest food environments that their patients likely reside in,” said Dr. Bevel. Clinicians also could consider the innovative approach of “food prescriptions” to help reduce the effects of deprived, built environments, he noted.
Looking ahead, next steps for research include determining the severity of association between food swamps and obesity-related cancer by varying factors such as cancer type, and examining any potential racial disparities between people living in these environments and obesity-related cancer, Dr. Bevel added.
Data provide foundation for multilevel interventions
The current study findings “raise a clarion call to elevate the discussion on food availability and access to ensure an equitable emphasis on both the importance of lifestyle factors and the upstream structural, economic, and environmental contexts that shape these behaviors at the individual level,” Karriem S. Watson, DHSc, MS, MPH, of the National Institutes of Health, Bethesda, Md., and Angela Odoms-Young, PhD, of Cornell University, Ithaca, N.Y., wrote in an accompanying editorial.
The findings provide a foundation for studies of obesity-related cancer outcomes that take the community environment into consideration, they added.
The causes of both obesity and cancer are complex, and the study findings suggest that the links between unhealthy food environments and obesity-related cancer may go beyond dietary consumption alone and extend to social and psychological factors, the editorialists noted.
“Whether dealing with the lack of access to healthy foods or an overabundance of unhealthy food, there is a critical need to develop additional research that explores the associations between obesity-related cancer mortality and food inequities,” they concluded.
The study received no outside funding. The researchers and the editorialists had no financial conflicts to disclose.
FROM JAMA ONCOLOGY
Autism and bone health: What you need to know
Many years ago, at the conclusion of a talk I gave on bone health in teens with anorexia nervosa, I was approached by a colleague, Ann Neumeyer, MD, medical director of the Lurie Center for Autism at Massachusetts General Hospital, Boston, who asked about bone health in children with autism spectrum disorder (ASD).
When I explained that there was little information about bone health in this patient population, she suggested that we learn and investigate together. Ann explained that she had observed that some of her patients with ASD had suffered fractures with minimal trauma, raising her concern about their bone health.
This was the beginning of a partnership that led us down the path of many grant submissions, some of which were funded and others that were not, to explore and investigate bone outcomes in children with ASD.
This applies to prepubertal children as well as older children and adolescents. One study showed that 28% and 33% of children with ASD 8-14 years old had very low bone density (z scores of ≤ –2) at the spine and hip, respectively, compared with 0% of typically developing controls.
Studies that have used sophisticated imaging techniques to determine bone strength have shown that it is lower at the forearm and lower leg in children with ASD versus neurotypical children.
These findings are of particular concern during the childhood and teenage years when bone is typically accrued at a rapid rate. A normal rate of bone accrual at this time of life is essential for optimal bone health in later life. While children with ASD gain bone mass at a similar rate as neurotypical controls, they start at a deficit and seem unable to “catch up.”
Further, people with ASD are more prone to certain kinds of fracture than those without the condition. For example, both children and adults with ASD have a high risk for hip fracture, while adult women with ASD have a higher risk for forearm and spine fractures. There is some protection against forearm fractures in children and adult men, probably because of markedly lower levels of physical activity, which would reduce fall risk.
Many of Ann’s patients with ASD had unusual or restricted diets, low levels of physical activity, and were on multiple medications. We have since learned that some factors that contribute to low bone density in ASD include lower levels of weight-bearing physical activity; lower muscle mass; low muscle tone; suboptimal dietary calcium and vitamin D intake; lower vitamin D levels; higher levels of the hormone cortisol, which has deleterious effects on bone; and use of medications that can lower bone density.
In order to mitigate the risk for low bone density and fractures, it is important to optimize physical activity while considering the child’s ability to safely engage in weight-bearing sports.
High-impact sports like gymnastics and jumping, or cross-impact sports like soccer, basketball, field hockey, and lacrosse, are particularly useful in this context, but many patients with ASD are not able to easily engage in typical team sports.
For such children, a prescribed amount of time spent walking, as well as weight and resistance training, could be helpful. The latter would also help increase muscle mass, a key modulator of bone health.
Other strategies include ensuring sufficient intake of calcium and vitamin D through diet and supplements. This can be a particular challenge for children with ASD on specialized diets, such as a gluten-free or dairy-free diet, which are deficient in calcium and vitamin D. Health care providers should check for intake of dairy and dairy products, as well as serum vitamin D levels, and prescribe supplements as needed.
All children should get at least 600 IUs of vitamin D and 1,000-1,300 mg of elemental calcium daily. That said, many with ASD need much higher quantities of vitamin D (1,000-4,000 IUs or more) to maintain levels in the normal range. This is particularly true for dark-skinned children and children with obesity, as well as those who have medical disorders that cause malabsorption.
Higher cortisol levels in the ASD patient population are harder to manage. Efforts to ease anxiety and depression may help reduce cortisol levels. Medications such as protein pump inhibitors and glucocorticosteroids can compromise bone health.
In addition, certain antipsychotics can cause marked elevations in prolactin which, in turn, can lower levels of estrogen and testosterone, which are very important for bone health. In such cases, the clinician should consider switching patients to a different, less detrimental medication or adjust the current medication so that patients receive the lowest possible effective dose.
Obesity is associated with increased fracture risk and with suboptimal bone accrual during childhood, so ensuring a healthy diet is important. This includes avoiding sugary beverages and reducing intake of processed food and juice.
Sometimes, particularly when a child has low bone density and a history of several low-trauma fractures, medications such as bisphosphonates should be considered to increase bone density.
Above all, as physicians who manage ASD, it is essential that we raise awareness about bone health among our colleagues, patients, and their families to help mitigate fracture risk.
Madhusmita Misra, MD, MPH, is chief of the Division of Pediatric Endocrinology at Mass General for Children, Boston.
A version of this article first appeared on Medscape.com.
Many years ago, at the conclusion of a talk I gave on bone health in teens with anorexia nervosa, I was approached by a colleague, Ann Neumeyer, MD, medical director of the Lurie Center for Autism at Massachusetts General Hospital, Boston, who asked about bone health in children with autism spectrum disorder (ASD).
When I explained that there was little information about bone health in this patient population, she suggested that we learn and investigate together. Ann explained that she had observed that some of her patients with ASD had suffered fractures with minimal trauma, raising her concern about their bone health.
This was the beginning of a partnership that led us down the path of many grant submissions, some of which were funded and others that were not, to explore and investigate bone outcomes in children with ASD.
This applies to prepubertal children as well as older children and adolescents. One study showed that 28% and 33% of children with ASD 8-14 years old had very low bone density (z scores of ≤ –2) at the spine and hip, respectively, compared with 0% of typically developing controls.
Studies that have used sophisticated imaging techniques to determine bone strength have shown that it is lower at the forearm and lower leg in children with ASD versus neurotypical children.
These findings are of particular concern during the childhood and teenage years when bone is typically accrued at a rapid rate. A normal rate of bone accrual at this time of life is essential for optimal bone health in later life. While children with ASD gain bone mass at a similar rate as neurotypical controls, they start at a deficit and seem unable to “catch up.”
Further, people with ASD are more prone to certain kinds of fracture than those without the condition. For example, both children and adults with ASD have a high risk for hip fracture, while adult women with ASD have a higher risk for forearm and spine fractures. There is some protection against forearm fractures in children and adult men, probably because of markedly lower levels of physical activity, which would reduce fall risk.
Many of Ann’s patients with ASD had unusual or restricted diets, low levels of physical activity, and were on multiple medications. We have since learned that some factors that contribute to low bone density in ASD include lower levels of weight-bearing physical activity; lower muscle mass; low muscle tone; suboptimal dietary calcium and vitamin D intake; lower vitamin D levels; higher levels of the hormone cortisol, which has deleterious effects on bone; and use of medications that can lower bone density.
In order to mitigate the risk for low bone density and fractures, it is important to optimize physical activity while considering the child’s ability to safely engage in weight-bearing sports.
High-impact sports like gymnastics and jumping, or cross-impact sports like soccer, basketball, field hockey, and lacrosse, are particularly useful in this context, but many patients with ASD are not able to easily engage in typical team sports.
For such children, a prescribed amount of time spent walking, as well as weight and resistance training, could be helpful. The latter would also help increase muscle mass, a key modulator of bone health.
Other strategies include ensuring sufficient intake of calcium and vitamin D through diet and supplements. This can be a particular challenge for children with ASD on specialized diets, such as a gluten-free or dairy-free diet, which are deficient in calcium and vitamin D. Health care providers should check for intake of dairy and dairy products, as well as serum vitamin D levels, and prescribe supplements as needed.
All children should get at least 600 IUs of vitamin D and 1,000-1,300 mg of elemental calcium daily. That said, many with ASD need much higher quantities of vitamin D (1,000-4,000 IUs or more) to maintain levels in the normal range. This is particularly true for dark-skinned children and children with obesity, as well as those who have medical disorders that cause malabsorption.
Higher cortisol levels in the ASD patient population are harder to manage. Efforts to ease anxiety and depression may help reduce cortisol levels. Medications such as protein pump inhibitors and glucocorticosteroids can compromise bone health.
In addition, certain antipsychotics can cause marked elevations in prolactin which, in turn, can lower levels of estrogen and testosterone, which are very important for bone health. In such cases, the clinician should consider switching patients to a different, less detrimental medication or adjust the current medication so that patients receive the lowest possible effective dose.
Obesity is associated with increased fracture risk and with suboptimal bone accrual during childhood, so ensuring a healthy diet is important. This includes avoiding sugary beverages and reducing intake of processed food and juice.
Sometimes, particularly when a child has low bone density and a history of several low-trauma fractures, medications such as bisphosphonates should be considered to increase bone density.
Above all, as physicians who manage ASD, it is essential that we raise awareness about bone health among our colleagues, patients, and their families to help mitigate fracture risk.
Madhusmita Misra, MD, MPH, is chief of the Division of Pediatric Endocrinology at Mass General for Children, Boston.
A version of this article first appeared on Medscape.com.
Many years ago, at the conclusion of a talk I gave on bone health in teens with anorexia nervosa, I was approached by a colleague, Ann Neumeyer, MD, medical director of the Lurie Center for Autism at Massachusetts General Hospital, Boston, who asked about bone health in children with autism spectrum disorder (ASD).
When I explained that there was little information about bone health in this patient population, she suggested that we learn and investigate together. Ann explained that she had observed that some of her patients with ASD had suffered fractures with minimal trauma, raising her concern about their bone health.
This was the beginning of a partnership that led us down the path of many grant submissions, some of which were funded and others that were not, to explore and investigate bone outcomes in children with ASD.
This applies to prepubertal children as well as older children and adolescents. One study showed that 28% and 33% of children with ASD 8-14 years old had very low bone density (z scores of ≤ –2) at the spine and hip, respectively, compared with 0% of typically developing controls.
Studies that have used sophisticated imaging techniques to determine bone strength have shown that it is lower at the forearm and lower leg in children with ASD versus neurotypical children.
These findings are of particular concern during the childhood and teenage years when bone is typically accrued at a rapid rate. A normal rate of bone accrual at this time of life is essential for optimal bone health in later life. While children with ASD gain bone mass at a similar rate as neurotypical controls, they start at a deficit and seem unable to “catch up.”
Further, people with ASD are more prone to certain kinds of fracture than those without the condition. For example, both children and adults with ASD have a high risk for hip fracture, while adult women with ASD have a higher risk for forearm and spine fractures. There is some protection against forearm fractures in children and adult men, probably because of markedly lower levels of physical activity, which would reduce fall risk.
Many of Ann’s patients with ASD had unusual or restricted diets, low levels of physical activity, and were on multiple medications. We have since learned that some factors that contribute to low bone density in ASD include lower levels of weight-bearing physical activity; lower muscle mass; low muscle tone; suboptimal dietary calcium and vitamin D intake; lower vitamin D levels; higher levels of the hormone cortisol, which has deleterious effects on bone; and use of medications that can lower bone density.
In order to mitigate the risk for low bone density and fractures, it is important to optimize physical activity while considering the child’s ability to safely engage in weight-bearing sports.
High-impact sports like gymnastics and jumping, or cross-impact sports like soccer, basketball, field hockey, and lacrosse, are particularly useful in this context, but many patients with ASD are not able to easily engage in typical team sports.
For such children, a prescribed amount of time spent walking, as well as weight and resistance training, could be helpful. The latter would also help increase muscle mass, a key modulator of bone health.
Other strategies include ensuring sufficient intake of calcium and vitamin D through diet and supplements. This can be a particular challenge for children with ASD on specialized diets, such as a gluten-free or dairy-free diet, which are deficient in calcium and vitamin D. Health care providers should check for intake of dairy and dairy products, as well as serum vitamin D levels, and prescribe supplements as needed.
All children should get at least 600 IUs of vitamin D and 1,000-1,300 mg of elemental calcium daily. That said, many with ASD need much higher quantities of vitamin D (1,000-4,000 IUs or more) to maintain levels in the normal range. This is particularly true for dark-skinned children and children with obesity, as well as those who have medical disorders that cause malabsorption.
Higher cortisol levels in the ASD patient population are harder to manage. Efforts to ease anxiety and depression may help reduce cortisol levels. Medications such as protein pump inhibitors and glucocorticosteroids can compromise bone health.
In addition, certain antipsychotics can cause marked elevations in prolactin which, in turn, can lower levels of estrogen and testosterone, which are very important for bone health. In such cases, the clinician should consider switching patients to a different, less detrimental medication or adjust the current medication so that patients receive the lowest possible effective dose.
Obesity is associated with increased fracture risk and with suboptimal bone accrual during childhood, so ensuring a healthy diet is important. This includes avoiding sugary beverages and reducing intake of processed food and juice.
Sometimes, particularly when a child has low bone density and a history of several low-trauma fractures, medications such as bisphosphonates should be considered to increase bone density.
Above all, as physicians who manage ASD, it is essential that we raise awareness about bone health among our colleagues, patients, and their families to help mitigate fracture risk.
Madhusmita Misra, MD, MPH, is chief of the Division of Pediatric Endocrinology at Mass General for Children, Boston.
A version of this article first appeared on Medscape.com.
Expert discusses which diets are best, based on the evidence
according to a speaker at the annual meeting of the American College of Physicians.
“Evidence from studies can help clinicians and their patients develop a successful dietary management plan and achieve optimal health,” said internist Michelle Hauser, MD, clinical associate professor at Stanford (Calif.) University. She also discussed evidence-based techniques to support patients in maintaining dietary modifications.
Predominantly plant‐based diets
Popular predominantly plant‐based diets include a Mediterranean diet, healthy vegetarian diet, predominantly whole-food plant‐based (WFPB) diet, and a dietary approach to stop hypertension (DASH).
The DASH diet was originally designed to help patients manage their blood pressure, but evidence suggests that it also can help adults with obesity lose weight. In contrast to the DASH diet, the Mediterranean diet is not low-fat and not very restrictive. Yet the evidence suggests that the Mediterranean diet is not only helpful for losing weight but also can reduce the risk of various chronic diseases, including obesity, type 2 diabetes, cardiovascular disease (CVD), and cancer, Dr. Hauser said. In addition, data suggest that the Mediterranean diet may reduce the risk of all-cause mortality and lower the levels of cholesterol.
“I like to highlight all these protective effects to my patients, because even if their goal is to lose weight, knowing that hard work pays off in additional ways can keep them motivated,” Dr. Hauser stated.
A healthy vegetarian diet and a WFPB diet are similar, and both are helpful in weight loss and management of total cholesterol and LDL‐C levels. Furthermore, healthy vegetarian and WFPB diets may reduce the risk of type 2 diabetes, CVD, and some cancers. Cohort study data suggest that progressively more vegetarian diets are associated with lower BMIs.
“My interpretation of these data is that predominantly plant-based diets rich in whole foods are healthful and can be done in a way that is sustainable for most,” said Dr. Hauser. However, this generally requires a lot of support at the outset to address gaps in knowledge, skills, and other potential barriers.
For example, she referred one obese patient at risk of diabetes and cardiovascular disease to a registered dietitian to develop a dietary plan. The patient also attended a behavioral medicine weight management program to learn strategies such as using smaller plates, and his family attended a healthy cooking class together to improve meal planning and cooking skills.
Time‐restricted feeding
There are numerous variations of time-restricted feeding, commonly referred to as intermittent fasting, but the principles are similar – limiting food intake to a specific window of time each day or week.
Although some studies have shown that time-restricted feeding may help patients reduce adiposity and improve lipid markers, most studies comparing time-restricted feeding to a calorie-restricted diet have shown little to no difference in weight-related outcomes, Dr. Hauser said.
These data suggest that time-restricted feeding may help patients with weight loss only if time restriction helps them reduce calorie intake. She also warned that time-restrictive feeding might cause late-night cravings and might not be helpful in individuals prone to food cravings.
Low‐carbohydrate and ketogenic diets
Losing muscle mass can prevent some people from dieting, but evidence suggests that a high-fat, very low-carbohydrate diet – also called a ketogenic diet – may help patients reduce weight and fat mass while preserving fat‐free mass, Dr. Hauser said.
The evidence regarding the usefulness of a low-carbohydrate (non-keto) diet is less clear because most studies compared it to a low-fat diet, and these two diets might lead to a similar extent of weight loss.
Rating the level of scientific evidence behind different diet options
Nutrition studies do no provide the same level of evidence as drug studies, said Dr. Hauser, because it is easier to conduct a randomized controlled trial of a drug versus placebo. Diets have many more variables, and it also takes much longer to observe most outcomes of a dietary change.
In addition, clinical trials of dietary interventions are typically short and focus on disease markers such as serum lipids and hemoglobin A1c levels. To obtain reliable information on the usefulness of a diet, researchers need to collect detailed health and lifestyle information from hundreds of thousands of people over several decades, which is not always feasible. “This is why meta-analyses of pooled dietary study data are more likely to yield dependable findings,” she noted.
Getting to know patients is essential to help them maintain diet modifications
When developing a diet plan for a patient, it is important to consider the sustainability of a dietary pattern. “The benefits of any healthy dietary change will only last as long as they can be maintained,” said Dr. Hauser. “Counseling someone on choosing an appropriate long-term dietary pattern requires getting to know them – taste preferences, food traditions, barriers, facilitators, food access, and time and cost restrictions.”
In an interview after the session, David Bittleman, MD, an internist at Veterans Affairs San Diego Health Care System, agreed that getting to know patients is essential for successfully advising them on diet.
“I always start developing a diet plan by trying to find out what [a patient’s] diet is like and what their goals are. I need to know what they are already doing in order to make suggestions about what they can do to make their diet healthier,” he said.
When asked about her approach to supporting patients in the long term, Dr. Hauser said that she recommends sequential, gradual changes. Dr. Hauser added that she suggests her patients prioritize implementing dietary changes that they are confident they can maintain.
Dr. Hauser and Dr. Bittleman report no relevant financial relationships.
according to a speaker at the annual meeting of the American College of Physicians.
“Evidence from studies can help clinicians and their patients develop a successful dietary management plan and achieve optimal health,” said internist Michelle Hauser, MD, clinical associate professor at Stanford (Calif.) University. She also discussed evidence-based techniques to support patients in maintaining dietary modifications.
Predominantly plant‐based diets
Popular predominantly plant‐based diets include a Mediterranean diet, healthy vegetarian diet, predominantly whole-food plant‐based (WFPB) diet, and a dietary approach to stop hypertension (DASH).
The DASH diet was originally designed to help patients manage their blood pressure, but evidence suggests that it also can help adults with obesity lose weight. In contrast to the DASH diet, the Mediterranean diet is not low-fat and not very restrictive. Yet the evidence suggests that the Mediterranean diet is not only helpful for losing weight but also can reduce the risk of various chronic diseases, including obesity, type 2 diabetes, cardiovascular disease (CVD), and cancer, Dr. Hauser said. In addition, data suggest that the Mediterranean diet may reduce the risk of all-cause mortality and lower the levels of cholesterol.
“I like to highlight all these protective effects to my patients, because even if their goal is to lose weight, knowing that hard work pays off in additional ways can keep them motivated,” Dr. Hauser stated.
A healthy vegetarian diet and a WFPB diet are similar, and both are helpful in weight loss and management of total cholesterol and LDL‐C levels. Furthermore, healthy vegetarian and WFPB diets may reduce the risk of type 2 diabetes, CVD, and some cancers. Cohort study data suggest that progressively more vegetarian diets are associated with lower BMIs.
“My interpretation of these data is that predominantly plant-based diets rich in whole foods are healthful and can be done in a way that is sustainable for most,” said Dr. Hauser. However, this generally requires a lot of support at the outset to address gaps in knowledge, skills, and other potential barriers.
For example, she referred one obese patient at risk of diabetes and cardiovascular disease to a registered dietitian to develop a dietary plan. The patient also attended a behavioral medicine weight management program to learn strategies such as using smaller plates, and his family attended a healthy cooking class together to improve meal planning and cooking skills.
Time‐restricted feeding
There are numerous variations of time-restricted feeding, commonly referred to as intermittent fasting, but the principles are similar – limiting food intake to a specific window of time each day or week.
Although some studies have shown that time-restricted feeding may help patients reduce adiposity and improve lipid markers, most studies comparing time-restricted feeding to a calorie-restricted diet have shown little to no difference in weight-related outcomes, Dr. Hauser said.
These data suggest that time-restricted feeding may help patients with weight loss only if time restriction helps them reduce calorie intake. She also warned that time-restrictive feeding might cause late-night cravings and might not be helpful in individuals prone to food cravings.
Low‐carbohydrate and ketogenic diets
Losing muscle mass can prevent some people from dieting, but evidence suggests that a high-fat, very low-carbohydrate diet – also called a ketogenic diet – may help patients reduce weight and fat mass while preserving fat‐free mass, Dr. Hauser said.
The evidence regarding the usefulness of a low-carbohydrate (non-keto) diet is less clear because most studies compared it to a low-fat diet, and these two diets might lead to a similar extent of weight loss.
Rating the level of scientific evidence behind different diet options
Nutrition studies do no provide the same level of evidence as drug studies, said Dr. Hauser, because it is easier to conduct a randomized controlled trial of a drug versus placebo. Diets have many more variables, and it also takes much longer to observe most outcomes of a dietary change.
In addition, clinical trials of dietary interventions are typically short and focus on disease markers such as serum lipids and hemoglobin A1c levels. To obtain reliable information on the usefulness of a diet, researchers need to collect detailed health and lifestyle information from hundreds of thousands of people over several decades, which is not always feasible. “This is why meta-analyses of pooled dietary study data are more likely to yield dependable findings,” she noted.
Getting to know patients is essential to help them maintain diet modifications
When developing a diet plan for a patient, it is important to consider the sustainability of a dietary pattern. “The benefits of any healthy dietary change will only last as long as they can be maintained,” said Dr. Hauser. “Counseling someone on choosing an appropriate long-term dietary pattern requires getting to know them – taste preferences, food traditions, barriers, facilitators, food access, and time and cost restrictions.”
In an interview after the session, David Bittleman, MD, an internist at Veterans Affairs San Diego Health Care System, agreed that getting to know patients is essential for successfully advising them on diet.
“I always start developing a diet plan by trying to find out what [a patient’s] diet is like and what their goals are. I need to know what they are already doing in order to make suggestions about what they can do to make their diet healthier,” he said.
When asked about her approach to supporting patients in the long term, Dr. Hauser said that she recommends sequential, gradual changes. Dr. Hauser added that she suggests her patients prioritize implementing dietary changes that they are confident they can maintain.
Dr. Hauser and Dr. Bittleman report no relevant financial relationships.
according to a speaker at the annual meeting of the American College of Physicians.
“Evidence from studies can help clinicians and their patients develop a successful dietary management plan and achieve optimal health,” said internist Michelle Hauser, MD, clinical associate professor at Stanford (Calif.) University. She also discussed evidence-based techniques to support patients in maintaining dietary modifications.
Predominantly plant‐based diets
Popular predominantly plant‐based diets include a Mediterranean diet, healthy vegetarian diet, predominantly whole-food plant‐based (WFPB) diet, and a dietary approach to stop hypertension (DASH).
The DASH diet was originally designed to help patients manage their blood pressure, but evidence suggests that it also can help adults with obesity lose weight. In contrast to the DASH diet, the Mediterranean diet is not low-fat and not very restrictive. Yet the evidence suggests that the Mediterranean diet is not only helpful for losing weight but also can reduce the risk of various chronic diseases, including obesity, type 2 diabetes, cardiovascular disease (CVD), and cancer, Dr. Hauser said. In addition, data suggest that the Mediterranean diet may reduce the risk of all-cause mortality and lower the levels of cholesterol.
“I like to highlight all these protective effects to my patients, because even if their goal is to lose weight, knowing that hard work pays off in additional ways can keep them motivated,” Dr. Hauser stated.
A healthy vegetarian diet and a WFPB diet are similar, and both are helpful in weight loss and management of total cholesterol and LDL‐C levels. Furthermore, healthy vegetarian and WFPB diets may reduce the risk of type 2 diabetes, CVD, and some cancers. Cohort study data suggest that progressively more vegetarian diets are associated with lower BMIs.
“My interpretation of these data is that predominantly plant-based diets rich in whole foods are healthful and can be done in a way that is sustainable for most,” said Dr. Hauser. However, this generally requires a lot of support at the outset to address gaps in knowledge, skills, and other potential barriers.
For example, she referred one obese patient at risk of diabetes and cardiovascular disease to a registered dietitian to develop a dietary plan. The patient also attended a behavioral medicine weight management program to learn strategies such as using smaller plates, and his family attended a healthy cooking class together to improve meal planning and cooking skills.
Time‐restricted feeding
There are numerous variations of time-restricted feeding, commonly referred to as intermittent fasting, but the principles are similar – limiting food intake to a specific window of time each day or week.
Although some studies have shown that time-restricted feeding may help patients reduce adiposity and improve lipid markers, most studies comparing time-restricted feeding to a calorie-restricted diet have shown little to no difference in weight-related outcomes, Dr. Hauser said.
These data suggest that time-restricted feeding may help patients with weight loss only if time restriction helps them reduce calorie intake. She also warned that time-restrictive feeding might cause late-night cravings and might not be helpful in individuals prone to food cravings.
Low‐carbohydrate and ketogenic diets
Losing muscle mass can prevent some people from dieting, but evidence suggests that a high-fat, very low-carbohydrate diet – also called a ketogenic diet – may help patients reduce weight and fat mass while preserving fat‐free mass, Dr. Hauser said.
The evidence regarding the usefulness of a low-carbohydrate (non-keto) diet is less clear because most studies compared it to a low-fat diet, and these two diets might lead to a similar extent of weight loss.
Rating the level of scientific evidence behind different diet options
Nutrition studies do no provide the same level of evidence as drug studies, said Dr. Hauser, because it is easier to conduct a randomized controlled trial of a drug versus placebo. Diets have many more variables, and it also takes much longer to observe most outcomes of a dietary change.
In addition, clinical trials of dietary interventions are typically short and focus on disease markers such as serum lipids and hemoglobin A1c levels. To obtain reliable information on the usefulness of a diet, researchers need to collect detailed health and lifestyle information from hundreds of thousands of people over several decades, which is not always feasible. “This is why meta-analyses of pooled dietary study data are more likely to yield dependable findings,” she noted.
Getting to know patients is essential to help them maintain diet modifications
When developing a diet plan for a patient, it is important to consider the sustainability of a dietary pattern. “The benefits of any healthy dietary change will only last as long as they can be maintained,” said Dr. Hauser. “Counseling someone on choosing an appropriate long-term dietary pattern requires getting to know them – taste preferences, food traditions, barriers, facilitators, food access, and time and cost restrictions.”
In an interview after the session, David Bittleman, MD, an internist at Veterans Affairs San Diego Health Care System, agreed that getting to know patients is essential for successfully advising them on diet.
“I always start developing a diet plan by trying to find out what [a patient’s] diet is like and what their goals are. I need to know what they are already doing in order to make suggestions about what they can do to make their diet healthier,” he said.
When asked about her approach to supporting patients in the long term, Dr. Hauser said that she recommends sequential, gradual changes. Dr. Hauser added that she suggests her patients prioritize implementing dietary changes that they are confident they can maintain.
Dr. Hauser and Dr. Bittleman report no relevant financial relationships.
AT INTERNAL MEDICINE 2023
Long-term impact of childhood trauma explained
WASHINGTON –
“We already knew childhood trauma is associated with the later development of depressive and anxiety disorders, but it’s been unclear what makes sufferers of early trauma more likely to develop these psychiatric conditions,” study investigator Erika Kuzminskaite, PhD candidate, department of psychiatry, Amsterdam University Medical Center (UMC), the Netherlands, told this news organization.
“The evidence now points to unbalanced stress systems as a possible cause of this vulnerability, and now the most important question is, how we can develop preventive interventions,” she added.
The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
Elevated cortisol, inflammation
The study included 2,779 adults from the Netherlands Study of Depression and Anxiety (NESDA). Two thirds of participants were female.
Participants retrospectively reported childhood trauma, defined as emotional, physical, or sexual abuse or emotional or physical neglect, before the age of 18 years. Severe trauma was defined as multiple types or increased frequency of abuse.
Of the total cohort, 48% reported experiencing some childhood trauma – 21% reported severe trauma, 27% reported mild trauma, and 42% reported no childhood trauma.
Among those with trauma, 89% had a current or remitted anxiety or depressive disorder, and 11% had no psychiatric sequelae. Among participants who reported no trauma, 68% had a current or remitted disorder, and 32% had no psychiatric disorders.
At baseline, researchers assessed markers of major bodily stress systems, including the hypothalamic-pituitary-adrenal (HPA) axis, the immune-inflammatory system, and the autonomic nervous system (ANS). They examined these markers separately and cumulatively.
In one model, investigators found that levels of cortisol and inflammation were significantly elevated in those with severe childhood trauma compared to those with no childhood trauma. The effects were largest for the cumulative markers for HPA-axis, inflammation, and all stress system markers (Cohen’s d = 0.23, 0.12, and 0.25, respectively). There was no association with ANS markers.
The results were partially explained by lifestyle, said Ms. Kuzminskaite, who noted that people with severe childhood trauma tend to have a higher body mass index, smoke more, and have other unhealthy habits that may represent a “coping” mechanism for trauma.
Those who experienced childhood trauma also have higher rates of other disorders, including asthma, diabetes, and cardiovascular disease. Ms. Kuzminskaite noted that people with childhood trauma have at least double the risk of cancer in later life.
When researchers adjusted for lifestyle factors and chronic conditions, the association for cortisol was reduced and that for inflammation disappeared. However, the cumulative inflammatory markers remained significant.
Another model examined lipopolysaccharide-stimulated (LPS) immune-inflammatory markers by childhood trauma severity. This provides a more “dynamic” measure of stress systems than looking only at static circulating levels in the blood, as was done in the first model, said Ms. Kuzminskaite.
“These levels should theoretically be more affected by experiences such as childhood trauma and they are also less sensitive to lifestyle.”
Here, researchers found significant positive associations with childhood trauma, especially severe trauma, after adjusting for lifestyle and health-related covariates (cumulative index d = 0.19).
“Almost all people with childhood trauma, especially severe trauma, had LPS-stimulated cytokines upregulated,” said Ms. Kuzminskaite. “So again, there is this dysregulation of immune system functioning in these subjects.”
And again, the strongest effect was for the cumulative index of all cytokines, she said.
Personalized interventions
Ms. Kuzminskaite noted the importance of learning the impact of early trauma on stress responses. “The goal is to eventually have personalized interventions for people with depression or anxiety related to childhood trauma, or even preventative interventions. If we know, for example, something is going wrong with a patient’s stress systems, we can suggest some therapeutic targets.”
Investigators in Amsterdam are examining the efficacy of mifepristone, which blocks progesterone and is used along with misoprostol for medication abortions and to treat high blood sugar. “The drug is supposed to reset the stress system functioning,” said Ms. Kuzminskaite.
It’s still important to target unhealthy lifestyle habits “that are really impacting the functioning of the stress systems,” she said. Lifestyle interventions could improve the efficacy of treatments for depression, for example, she added.
Luana Marques, PhD, associate professor, department of psychiatry, Harvard Medical School, Boston, said such research is important.
“It reveals the potentially extensive and long-lasting impact of childhood trauma on functioning. The findings underscore the importance of equipping at-risk and trauma-exposed youth with evidence-based skills for managing stress,” she said.
No conflicts of interest were reported.
A version of this article first appeared on Medscape.com.
WASHINGTON –
“We already knew childhood trauma is associated with the later development of depressive and anxiety disorders, but it’s been unclear what makes sufferers of early trauma more likely to develop these psychiatric conditions,” study investigator Erika Kuzminskaite, PhD candidate, department of psychiatry, Amsterdam University Medical Center (UMC), the Netherlands, told this news organization.
“The evidence now points to unbalanced stress systems as a possible cause of this vulnerability, and now the most important question is, how we can develop preventive interventions,” she added.
The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
Elevated cortisol, inflammation
The study included 2,779 adults from the Netherlands Study of Depression and Anxiety (NESDA). Two thirds of participants were female.
Participants retrospectively reported childhood trauma, defined as emotional, physical, or sexual abuse or emotional or physical neglect, before the age of 18 years. Severe trauma was defined as multiple types or increased frequency of abuse.
Of the total cohort, 48% reported experiencing some childhood trauma – 21% reported severe trauma, 27% reported mild trauma, and 42% reported no childhood trauma.
Among those with trauma, 89% had a current or remitted anxiety or depressive disorder, and 11% had no psychiatric sequelae. Among participants who reported no trauma, 68% had a current or remitted disorder, and 32% had no psychiatric disorders.
At baseline, researchers assessed markers of major bodily stress systems, including the hypothalamic-pituitary-adrenal (HPA) axis, the immune-inflammatory system, and the autonomic nervous system (ANS). They examined these markers separately and cumulatively.
In one model, investigators found that levels of cortisol and inflammation were significantly elevated in those with severe childhood trauma compared to those with no childhood trauma. The effects were largest for the cumulative markers for HPA-axis, inflammation, and all stress system markers (Cohen’s d = 0.23, 0.12, and 0.25, respectively). There was no association with ANS markers.
The results were partially explained by lifestyle, said Ms. Kuzminskaite, who noted that people with severe childhood trauma tend to have a higher body mass index, smoke more, and have other unhealthy habits that may represent a “coping” mechanism for trauma.
Those who experienced childhood trauma also have higher rates of other disorders, including asthma, diabetes, and cardiovascular disease. Ms. Kuzminskaite noted that people with childhood trauma have at least double the risk of cancer in later life.
When researchers adjusted for lifestyle factors and chronic conditions, the association for cortisol was reduced and that for inflammation disappeared. However, the cumulative inflammatory markers remained significant.
Another model examined lipopolysaccharide-stimulated (LPS) immune-inflammatory markers by childhood trauma severity. This provides a more “dynamic” measure of stress systems than looking only at static circulating levels in the blood, as was done in the first model, said Ms. Kuzminskaite.
“These levels should theoretically be more affected by experiences such as childhood trauma and they are also less sensitive to lifestyle.”
Here, researchers found significant positive associations with childhood trauma, especially severe trauma, after adjusting for lifestyle and health-related covariates (cumulative index d = 0.19).
“Almost all people with childhood trauma, especially severe trauma, had LPS-stimulated cytokines upregulated,” said Ms. Kuzminskaite. “So again, there is this dysregulation of immune system functioning in these subjects.”
And again, the strongest effect was for the cumulative index of all cytokines, she said.
Personalized interventions
Ms. Kuzminskaite noted the importance of learning the impact of early trauma on stress responses. “The goal is to eventually have personalized interventions for people with depression or anxiety related to childhood trauma, or even preventative interventions. If we know, for example, something is going wrong with a patient’s stress systems, we can suggest some therapeutic targets.”
Investigators in Amsterdam are examining the efficacy of mifepristone, which blocks progesterone and is used along with misoprostol for medication abortions and to treat high blood sugar. “The drug is supposed to reset the stress system functioning,” said Ms. Kuzminskaite.
It’s still important to target unhealthy lifestyle habits “that are really impacting the functioning of the stress systems,” she said. Lifestyle interventions could improve the efficacy of treatments for depression, for example, she added.
Luana Marques, PhD, associate professor, department of psychiatry, Harvard Medical School, Boston, said such research is important.
“It reveals the potentially extensive and long-lasting impact of childhood trauma on functioning. The findings underscore the importance of equipping at-risk and trauma-exposed youth with evidence-based skills for managing stress,” she said.
No conflicts of interest were reported.
A version of this article first appeared on Medscape.com.
WASHINGTON –
“We already knew childhood trauma is associated with the later development of depressive and anxiety disorders, but it’s been unclear what makes sufferers of early trauma more likely to develop these psychiatric conditions,” study investigator Erika Kuzminskaite, PhD candidate, department of psychiatry, Amsterdam University Medical Center (UMC), the Netherlands, told this news organization.
“The evidence now points to unbalanced stress systems as a possible cause of this vulnerability, and now the most important question is, how we can develop preventive interventions,” she added.
The findings were presented as part of the Anxiety and Depression Association of America Anxiety & Depression conference.
Elevated cortisol, inflammation
The study included 2,779 adults from the Netherlands Study of Depression and Anxiety (NESDA). Two thirds of participants were female.
Participants retrospectively reported childhood trauma, defined as emotional, physical, or sexual abuse or emotional or physical neglect, before the age of 18 years. Severe trauma was defined as multiple types or increased frequency of abuse.
Of the total cohort, 48% reported experiencing some childhood trauma – 21% reported severe trauma, 27% reported mild trauma, and 42% reported no childhood trauma.
Among those with trauma, 89% had a current or remitted anxiety or depressive disorder, and 11% had no psychiatric sequelae. Among participants who reported no trauma, 68% had a current or remitted disorder, and 32% had no psychiatric disorders.
At baseline, researchers assessed markers of major bodily stress systems, including the hypothalamic-pituitary-adrenal (HPA) axis, the immune-inflammatory system, and the autonomic nervous system (ANS). They examined these markers separately and cumulatively.
In one model, investigators found that levels of cortisol and inflammation were significantly elevated in those with severe childhood trauma compared to those with no childhood trauma. The effects were largest for the cumulative markers for HPA-axis, inflammation, and all stress system markers (Cohen’s d = 0.23, 0.12, and 0.25, respectively). There was no association with ANS markers.
The results were partially explained by lifestyle, said Ms. Kuzminskaite, who noted that people with severe childhood trauma tend to have a higher body mass index, smoke more, and have other unhealthy habits that may represent a “coping” mechanism for trauma.
Those who experienced childhood trauma also have higher rates of other disorders, including asthma, diabetes, and cardiovascular disease. Ms. Kuzminskaite noted that people with childhood trauma have at least double the risk of cancer in later life.
When researchers adjusted for lifestyle factors and chronic conditions, the association for cortisol was reduced and that for inflammation disappeared. However, the cumulative inflammatory markers remained significant.
Another model examined lipopolysaccharide-stimulated (LPS) immune-inflammatory markers by childhood trauma severity. This provides a more “dynamic” measure of stress systems than looking only at static circulating levels in the blood, as was done in the first model, said Ms. Kuzminskaite.
“These levels should theoretically be more affected by experiences such as childhood trauma and they are also less sensitive to lifestyle.”
Here, researchers found significant positive associations with childhood trauma, especially severe trauma, after adjusting for lifestyle and health-related covariates (cumulative index d = 0.19).
“Almost all people with childhood trauma, especially severe trauma, had LPS-stimulated cytokines upregulated,” said Ms. Kuzminskaite. “So again, there is this dysregulation of immune system functioning in these subjects.”
And again, the strongest effect was for the cumulative index of all cytokines, she said.
Personalized interventions
Ms. Kuzminskaite noted the importance of learning the impact of early trauma on stress responses. “The goal is to eventually have personalized interventions for people with depression or anxiety related to childhood trauma, or even preventative interventions. If we know, for example, something is going wrong with a patient’s stress systems, we can suggest some therapeutic targets.”
Investigators in Amsterdam are examining the efficacy of mifepristone, which blocks progesterone and is used along with misoprostol for medication abortions and to treat high blood sugar. “The drug is supposed to reset the stress system functioning,” said Ms. Kuzminskaite.
It’s still important to target unhealthy lifestyle habits “that are really impacting the functioning of the stress systems,” she said. Lifestyle interventions could improve the efficacy of treatments for depression, for example, she added.
Luana Marques, PhD, associate professor, department of psychiatry, Harvard Medical School, Boston, said such research is important.
“It reveals the potentially extensive and long-lasting impact of childhood trauma on functioning. The findings underscore the importance of equipping at-risk and trauma-exposed youth with evidence-based skills for managing stress,” she said.
No conflicts of interest were reported.
A version of this article first appeared on Medscape.com.
AT ADAA 2023
New drugs in primary care: Lessons learned from COVID-19
SAN DIEGO – – plus it has helped keep many patients out of the hospital, according to a presenter at the annual meeting of the American College of Physicians.
Nirmatrelvir-ritonavir was granted emergency use authorization by the FDA late in 2021 to prevent progression to severe disease when COVID-19 cases and deaths were surging, and the Delta and Omicron variants started to spread.
Gerald Smetana, MD, an internist at Beth Israel Deaconess Medical Center in Boston, discussed nirmatrelvir-ritonavir as an example of how new drugs relevant to primary care can have a profound impact on public health.
Understanding the mechanism of action
Nirmatrelvir is the active agent of this combination and inhibits the SARS-CoV-2 main protease (Mpro), which is required for viral replication. In contrast to the SARS-CoV-2 spike protein, Mpro is highly conserved in coronaviruses and rarely acquires mutations. Therefore, unlike monoclonal antibodies targeting the spike protein, nirmatrelvir is active against known Omicron variants and is predicted to remain active against new variants that may emerge. The HIV1 protease inhibitor ritonavir has no activity against SARS-CoV-2. It can help increase the serum concentration of nirmatrelvir by inhibiting its metabolization.
“Although the details are not important for prescribing internists, having a basic understanding of the mechanism of action can help [doctors] better understand for which patients the drugs are indicated,” said Dr. Smetana, also a professor of medicine at Harvard Medical School, Boston. This is particularly important for newly approved drugs with a lot of new information to digest.
“Knowing the mechanisms of action of new drugs can help us predict their efficacy and potential side effects,” said Hubertus Kiefl, MD, an internist at Beth Israel Deaconess Medical Center and a lecturer at Harvard Medical School, during an interview after the session.
Understanding how drugs work also can help clinicians make better decisions, such as avoiding the use of a monoclonal antibody during a surge of a new variant with mutations in surface proteins or carefully managing the use of nirmatrelvir-ritonavir in patients who take certain medications that would cause potentially serious drug-drug interactions, Dr. Kiefl added.
Nirmatrelvir-ritonavir reduces the risk of hospitalization – but only in high-risk patients.
Dr. Smetana presented published data from the EPIC-HR study, a pivotal phase 2-3 clinical trial in 2,246 adult patients with COVID-19, all of whom were unvaccinated. Additionally, all patients had at least one risk factor for progression to severe disease.
When initiated 5 days after symptom onset or earlier, treatment with 300 mg nirmatrelvir plus 100 mg ritonavir twice a day for 5 days led to an 89% relative risk reduction in COVID-19–related hospitalization or death through day 28, compared with placebo.
Subgroup analyses showed that some patients benefited more than others. The highest risk reduction after treatment with nirmatrelvir-ritonavir was observed in patients at least 65 years old.
“It is important to remember that all the patients of this study were unvaccinated and [had] not had prior SARS-CoV-2 infection. This study population isn’t representative of most patients we are seeing today,” said Dr. Smetana.
Unpublished data from a study of standard-risk patients showed a nonsignificant reduction in the risk of hospitalization or death, he said. The study was stopped because of the low rates of hospitalization and death.
Effective in real world, but less so than in clinical trials
The fact that the patient cohort in the EPIC-HR trial was different from the patients internists see today makes real-world data critical for determining the usefulness of nirmatrelvir-ritonavir in everyday practice, Dr. Smetana said.
A real-world study from Israel conducted during the first Omicron wave (January to March 2022) showed that treatment with nirmatrelvir alone substantially reduced the relative risk of hospitalization in adults older than 65, with no evidence of benefit in adults aged 40-65. Dr. Smetana highlighted that, unlike the EPIC-HR cohort, most patients in the Israeli study had prior immunity due to vaccination or prior SARS-CoV-2 infection.
Many drug-drug interactions, but they can be managed
Nirmatrelvir-ritonavir interacts with many drugs, some of which are commonly used by primary care patients.
To help internists identify drug-drug interactions, Dr. Smetana proposed the use of the Liverpool COVID-19 Drug Interactions Checker, an intuitive tool that can help prescribers identify potential drug-drug interactions, categorize them based on severity, and identify management strategies.
This tool is specific to COVID-19 drugs. The Liverpool group also offers online drug interaction checkers for HIV, hepatitis, and cancer. “We need more tools like this to help improve the safe use of new drugs,” Dr. Smetana said.
To manage drug interactions, according to Dr. Smetana, U.S. treatment guidelines offer the following three options:
- Prescribe an alternative COVID therapy.
- Temporarily withhold concomitant medication if clinically appropriate.
- Adjust the dose of concomitant medication and monitor for adverse effects.
Medication doses that are withheld or modified should be continued through 3 days after completing nirmatrelvir-ritonavir, he added.
Important considerations
Commenting on things to consider for patients with COVID-19, Dr. Smetana said that there is a short window after symptom onset when nirmatrelvir-ritonavir can be prescribed, and safety in pregnancy is not known. There is also uncertainty regarding funding of nirmatrelvir-ritonavir prescriptions after the state of emergency is lifted. He reminded attendees that, although nirmatrelvir-ritonavir is the preferred first-line treatment for high-risk patients, another antiviral agent, molnupiravir, is also available and might be more appropriate for some patients.
He also cautioned about prescribing new drugs off label for indications that are not yet FDA-approved. “We are often stewards of limited resources when new drugs first become available but are not yet in sufficient supply to meet demand. Limiting our prescribing to FDA-approved indications helps to ensure equitable access,” he said.
Dr. Smetana and Dr. Kiefl reported no disclosures.
SAN DIEGO – – plus it has helped keep many patients out of the hospital, according to a presenter at the annual meeting of the American College of Physicians.
Nirmatrelvir-ritonavir was granted emergency use authorization by the FDA late in 2021 to prevent progression to severe disease when COVID-19 cases and deaths were surging, and the Delta and Omicron variants started to spread.
Gerald Smetana, MD, an internist at Beth Israel Deaconess Medical Center in Boston, discussed nirmatrelvir-ritonavir as an example of how new drugs relevant to primary care can have a profound impact on public health.
Understanding the mechanism of action
Nirmatrelvir is the active agent of this combination and inhibits the SARS-CoV-2 main protease (Mpro), which is required for viral replication. In contrast to the SARS-CoV-2 spike protein, Mpro is highly conserved in coronaviruses and rarely acquires mutations. Therefore, unlike monoclonal antibodies targeting the spike protein, nirmatrelvir is active against known Omicron variants and is predicted to remain active against new variants that may emerge. The HIV1 protease inhibitor ritonavir has no activity against SARS-CoV-2. It can help increase the serum concentration of nirmatrelvir by inhibiting its metabolization.
“Although the details are not important for prescribing internists, having a basic understanding of the mechanism of action can help [doctors] better understand for which patients the drugs are indicated,” said Dr. Smetana, also a professor of medicine at Harvard Medical School, Boston. This is particularly important for newly approved drugs with a lot of new information to digest.
“Knowing the mechanisms of action of new drugs can help us predict their efficacy and potential side effects,” said Hubertus Kiefl, MD, an internist at Beth Israel Deaconess Medical Center and a lecturer at Harvard Medical School, during an interview after the session.
Understanding how drugs work also can help clinicians make better decisions, such as avoiding the use of a monoclonal antibody during a surge of a new variant with mutations in surface proteins or carefully managing the use of nirmatrelvir-ritonavir in patients who take certain medications that would cause potentially serious drug-drug interactions, Dr. Kiefl added.
Nirmatrelvir-ritonavir reduces the risk of hospitalization – but only in high-risk patients.
Dr. Smetana presented published data from the EPIC-HR study, a pivotal phase 2-3 clinical trial in 2,246 adult patients with COVID-19, all of whom were unvaccinated. Additionally, all patients had at least one risk factor for progression to severe disease.
When initiated 5 days after symptom onset or earlier, treatment with 300 mg nirmatrelvir plus 100 mg ritonavir twice a day for 5 days led to an 89% relative risk reduction in COVID-19–related hospitalization or death through day 28, compared with placebo.
Subgroup analyses showed that some patients benefited more than others. The highest risk reduction after treatment with nirmatrelvir-ritonavir was observed in patients at least 65 years old.
“It is important to remember that all the patients of this study were unvaccinated and [had] not had prior SARS-CoV-2 infection. This study population isn’t representative of most patients we are seeing today,” said Dr. Smetana.
Unpublished data from a study of standard-risk patients showed a nonsignificant reduction in the risk of hospitalization or death, he said. The study was stopped because of the low rates of hospitalization and death.
Effective in real world, but less so than in clinical trials
The fact that the patient cohort in the EPIC-HR trial was different from the patients internists see today makes real-world data critical for determining the usefulness of nirmatrelvir-ritonavir in everyday practice, Dr. Smetana said.
A real-world study from Israel conducted during the first Omicron wave (January to March 2022) showed that treatment with nirmatrelvir alone substantially reduced the relative risk of hospitalization in adults older than 65, with no evidence of benefit in adults aged 40-65. Dr. Smetana highlighted that, unlike the EPIC-HR cohort, most patients in the Israeli study had prior immunity due to vaccination or prior SARS-CoV-2 infection.
Many drug-drug interactions, but they can be managed
Nirmatrelvir-ritonavir interacts with many drugs, some of which are commonly used by primary care patients.
To help internists identify drug-drug interactions, Dr. Smetana proposed the use of the Liverpool COVID-19 Drug Interactions Checker, an intuitive tool that can help prescribers identify potential drug-drug interactions, categorize them based on severity, and identify management strategies.
This tool is specific to COVID-19 drugs. The Liverpool group also offers online drug interaction checkers for HIV, hepatitis, and cancer. “We need more tools like this to help improve the safe use of new drugs,” Dr. Smetana said.
To manage drug interactions, according to Dr. Smetana, U.S. treatment guidelines offer the following three options:
- Prescribe an alternative COVID therapy.
- Temporarily withhold concomitant medication if clinically appropriate.
- Adjust the dose of concomitant medication and monitor for adverse effects.
Medication doses that are withheld or modified should be continued through 3 days after completing nirmatrelvir-ritonavir, he added.
Important considerations
Commenting on things to consider for patients with COVID-19, Dr. Smetana said that there is a short window after symptom onset when nirmatrelvir-ritonavir can be prescribed, and safety in pregnancy is not known. There is also uncertainty regarding funding of nirmatrelvir-ritonavir prescriptions after the state of emergency is lifted. He reminded attendees that, although nirmatrelvir-ritonavir is the preferred first-line treatment for high-risk patients, another antiviral agent, molnupiravir, is also available and might be more appropriate for some patients.
He also cautioned about prescribing new drugs off label for indications that are not yet FDA-approved. “We are often stewards of limited resources when new drugs first become available but are not yet in sufficient supply to meet demand. Limiting our prescribing to FDA-approved indications helps to ensure equitable access,” he said.
Dr. Smetana and Dr. Kiefl reported no disclosures.
SAN DIEGO – – plus it has helped keep many patients out of the hospital, according to a presenter at the annual meeting of the American College of Physicians.
Nirmatrelvir-ritonavir was granted emergency use authorization by the FDA late in 2021 to prevent progression to severe disease when COVID-19 cases and deaths were surging, and the Delta and Omicron variants started to spread.
Gerald Smetana, MD, an internist at Beth Israel Deaconess Medical Center in Boston, discussed nirmatrelvir-ritonavir as an example of how new drugs relevant to primary care can have a profound impact on public health.
Understanding the mechanism of action
Nirmatrelvir is the active agent of this combination and inhibits the SARS-CoV-2 main protease (Mpro), which is required for viral replication. In contrast to the SARS-CoV-2 spike protein, Mpro is highly conserved in coronaviruses and rarely acquires mutations. Therefore, unlike monoclonal antibodies targeting the spike protein, nirmatrelvir is active against known Omicron variants and is predicted to remain active against new variants that may emerge. The HIV1 protease inhibitor ritonavir has no activity against SARS-CoV-2. It can help increase the serum concentration of nirmatrelvir by inhibiting its metabolization.
“Although the details are not important for prescribing internists, having a basic understanding of the mechanism of action can help [doctors] better understand for which patients the drugs are indicated,” said Dr. Smetana, also a professor of medicine at Harvard Medical School, Boston. This is particularly important for newly approved drugs with a lot of new information to digest.
“Knowing the mechanisms of action of new drugs can help us predict their efficacy and potential side effects,” said Hubertus Kiefl, MD, an internist at Beth Israel Deaconess Medical Center and a lecturer at Harvard Medical School, during an interview after the session.
Understanding how drugs work also can help clinicians make better decisions, such as avoiding the use of a monoclonal antibody during a surge of a new variant with mutations in surface proteins or carefully managing the use of nirmatrelvir-ritonavir in patients who take certain medications that would cause potentially serious drug-drug interactions, Dr. Kiefl added.
Nirmatrelvir-ritonavir reduces the risk of hospitalization – but only in high-risk patients.
Dr. Smetana presented published data from the EPIC-HR study, a pivotal phase 2-3 clinical trial in 2,246 adult patients with COVID-19, all of whom were unvaccinated. Additionally, all patients had at least one risk factor for progression to severe disease.
When initiated 5 days after symptom onset or earlier, treatment with 300 mg nirmatrelvir plus 100 mg ritonavir twice a day for 5 days led to an 89% relative risk reduction in COVID-19–related hospitalization or death through day 28, compared with placebo.
Subgroup analyses showed that some patients benefited more than others. The highest risk reduction after treatment with nirmatrelvir-ritonavir was observed in patients at least 65 years old.
“It is important to remember that all the patients of this study were unvaccinated and [had] not had prior SARS-CoV-2 infection. This study population isn’t representative of most patients we are seeing today,” said Dr. Smetana.
Unpublished data from a study of standard-risk patients showed a nonsignificant reduction in the risk of hospitalization or death, he said. The study was stopped because of the low rates of hospitalization and death.
Effective in real world, but less so than in clinical trials
The fact that the patient cohort in the EPIC-HR trial was different from the patients internists see today makes real-world data critical for determining the usefulness of nirmatrelvir-ritonavir in everyday practice, Dr. Smetana said.
A real-world study from Israel conducted during the first Omicron wave (January to March 2022) showed that treatment with nirmatrelvir alone substantially reduced the relative risk of hospitalization in adults older than 65, with no evidence of benefit in adults aged 40-65. Dr. Smetana highlighted that, unlike the EPIC-HR cohort, most patients in the Israeli study had prior immunity due to vaccination or prior SARS-CoV-2 infection.
Many drug-drug interactions, but they can be managed
Nirmatrelvir-ritonavir interacts with many drugs, some of which are commonly used by primary care patients.
To help internists identify drug-drug interactions, Dr. Smetana proposed the use of the Liverpool COVID-19 Drug Interactions Checker, an intuitive tool that can help prescribers identify potential drug-drug interactions, categorize them based on severity, and identify management strategies.
This tool is specific to COVID-19 drugs. The Liverpool group also offers online drug interaction checkers for HIV, hepatitis, and cancer. “We need more tools like this to help improve the safe use of new drugs,” Dr. Smetana said.
To manage drug interactions, according to Dr. Smetana, U.S. treatment guidelines offer the following three options:
- Prescribe an alternative COVID therapy.
- Temporarily withhold concomitant medication if clinically appropriate.
- Adjust the dose of concomitant medication and monitor for adverse effects.
Medication doses that are withheld or modified should be continued through 3 days after completing nirmatrelvir-ritonavir, he added.
Important considerations
Commenting on things to consider for patients with COVID-19, Dr. Smetana said that there is a short window after symptom onset when nirmatrelvir-ritonavir can be prescribed, and safety in pregnancy is not known. There is also uncertainty regarding funding of nirmatrelvir-ritonavir prescriptions after the state of emergency is lifted. He reminded attendees that, although nirmatrelvir-ritonavir is the preferred first-line treatment for high-risk patients, another antiviral agent, molnupiravir, is also available and might be more appropriate for some patients.
He also cautioned about prescribing new drugs off label for indications that are not yet FDA-approved. “We are often stewards of limited resources when new drugs first become available but are not yet in sufficient supply to meet demand. Limiting our prescribing to FDA-approved indications helps to ensure equitable access,” he said.
Dr. Smetana and Dr. Kiefl reported no disclosures.
AT INTERNAL MEDICINE 2023
“Terrific progress”: Adding blinatumomab for infant leukemia
.
Two-year disease-free and overall survival measures, as well as the percentage of children who had complete minimal residual disease (MRD) responses, were substantially higher among the 30 infants in the study than in historical controls treated with the same chemotherapy backbone in an earlier trial, Interfant-06.
“These outcome data are very promising, given the poor survival and lack of improvements in outcomes among infants with KMT2A-rearranged ALL in recent decades,” said the investigators, led by Inge M. van der Sluis, MD, PhD, a hematologist-oncologist at Princess Maxima Center for Pediatric Oncology in Utrecht, the Netherlands.
“The low incidence of relapse after treatment with blinatumomab is remarkable, given that in historical controls relapses occur frequently and early during therapy,” the investigators stated. Although the “follow-up time was relatively short” in the study, “it included the period historically defined” as being at high risk of relapse, they said.
The team suggested that future research should assess whether infants benefit from multiple courses of blinatumomab, rather than the one course used in the study, and whether blinatumomab plus chemotherapy can replace stem cell transplants for high-risk infants.
Pediatric community responds
There was excitement on Twitter about the results; a number of pediatric blood cancer specialists were impressed and posted the study on that platform. Comments included, “Wow! After years of stagnation, a huge step forward for infant leukemia” and “great news for infant lymphoblastic leukemia.”
Akshay Sharma, MBBS, a pediatric bone marrow transplant and cellular therapy specialist at St. Jude Children’s Research Hospital, Memphis, also posted. He said in an interview that the findings are “very exciting.”
The “outcomes of children diagnosed with leukemia in their infancy, particularly if they have a KMT2A rearrangement, have been dismal. This is terrific progress and a testament to the role that immunotherapy and novel agents will be playing in treatment of several malignant diseases in the decade to come,” he said.
Another poster, Pratik “Tik” Patel, MD, a pediatric hematology/oncology fellow at Emory University in Atlanta, told this news organization that the study “is welcome news to pediatric oncologists” and highlights “the success in incorporating newer immune-based therapeutics upfront in treatment rather than in relapsed/refractory settings.”
The National Cancer Institute–funded Children’s Oncology Group is thinking the same way. The group is launching a large, randomized trial to test if adding blinatumomab to chemotherapy upfront for B-cell acute lymphoblastic leukemia and lymphoblastic lymphoma improves outcomes in children and young adults aged 1-31 years. Results are due after 2029.
Study details
Blinatumomab is an expensive “T-cell engager” that helps cytotoxic CD3+T cells link to and destroy leukemic CD19+ B cells. Past studies have shown that it’s safe and works in older children and adults with B-lineage ALL after intensive chemotherapy, but until now the approach hadn’t been tested in infants, the investigators said.
The 30 subjects in the study were under a year old and newly diagnosed with KMT2A-rearranged ALL. They were treated with the Interfant-06 chemotherapy regimen – cytosine arabinoside and other agents – plus one postinduction course of blinatumomab at 15 micrograms/m2 per day as a 4-week continuous infusion. Eight of nine high-risk patients had allogeneic hematopoietic stem cell transplants.
Overall survival was 93.3% over a median follow up of 26.3 months, substantially higher than the 65.8% in the Interfant-06 trial. Two-year disease-free survival was 81.6% versus 49.4% in Interfant-06.
Sixteen patients (53%) were MRD negative after blinatumomab infusion and 12 (40%) had low levels of MRD. All of the children who continued chemotherapy went on to become MRD negative.
There were no permanent blinatumomab discontinuations and no treatment related deaths. Serious toxic effects were consistent with those in older patients and included four fevers, four infections, and one case each of hypertension and vomiting.
There were no cases of severe cytokine release syndrome (CRS) because of the low tumor burden of the subjects. Likewise, there were no obvious neurologic adverse events – like CRS, a particular concern with blinatumomab – but “we cannot rule out underreporting of mild neurologic symptoms that may have been unrecognized in infants,” the investigators said.
Patients who relapsed in the study had CNS involvement at relapse. “This underscores the need for adequate intrathecal chemotherapy during the blinatumomab infusion, because the efficacy of blinatumomab for the treatment of CNS leukemia may be limited,” they said.
The work was supported by Amgen, the maker of blinatumomab, as well as the Princess Maxima Center Foundation, the Danish Childhood Cancer Foundation, and others. Dr. Sluis is a consultant and researcher for Amgen. Five other authors were also consultants/advisers/researchers for the company. Dr. Sharma and Dr. Patel didn’t have any relevant disclosures.
.
Two-year disease-free and overall survival measures, as well as the percentage of children who had complete minimal residual disease (MRD) responses, were substantially higher among the 30 infants in the study than in historical controls treated with the same chemotherapy backbone in an earlier trial, Interfant-06.
“These outcome data are very promising, given the poor survival and lack of improvements in outcomes among infants with KMT2A-rearranged ALL in recent decades,” said the investigators, led by Inge M. van der Sluis, MD, PhD, a hematologist-oncologist at Princess Maxima Center for Pediatric Oncology in Utrecht, the Netherlands.
“The low incidence of relapse after treatment with blinatumomab is remarkable, given that in historical controls relapses occur frequently and early during therapy,” the investigators stated. Although the “follow-up time was relatively short” in the study, “it included the period historically defined” as being at high risk of relapse, they said.
The team suggested that future research should assess whether infants benefit from multiple courses of blinatumomab, rather than the one course used in the study, and whether blinatumomab plus chemotherapy can replace stem cell transplants for high-risk infants.
Pediatric community responds
There was excitement on Twitter about the results; a number of pediatric blood cancer specialists were impressed and posted the study on that platform. Comments included, “Wow! After years of stagnation, a huge step forward for infant leukemia” and “great news for infant lymphoblastic leukemia.”
Akshay Sharma, MBBS, a pediatric bone marrow transplant and cellular therapy specialist at St. Jude Children’s Research Hospital, Memphis, also posted. He said in an interview that the findings are “very exciting.”
The “outcomes of children diagnosed with leukemia in their infancy, particularly if they have a KMT2A rearrangement, have been dismal. This is terrific progress and a testament to the role that immunotherapy and novel agents will be playing in treatment of several malignant diseases in the decade to come,” he said.
Another poster, Pratik “Tik” Patel, MD, a pediatric hematology/oncology fellow at Emory University in Atlanta, told this news organization that the study “is welcome news to pediatric oncologists” and highlights “the success in incorporating newer immune-based therapeutics upfront in treatment rather than in relapsed/refractory settings.”
The National Cancer Institute–funded Children’s Oncology Group is thinking the same way. The group is launching a large, randomized trial to test if adding blinatumomab to chemotherapy upfront for B-cell acute lymphoblastic leukemia and lymphoblastic lymphoma improves outcomes in children and young adults aged 1-31 years. Results are due after 2029.
Study details
Blinatumomab is an expensive “T-cell engager” that helps cytotoxic CD3+T cells link to and destroy leukemic CD19+ B cells. Past studies have shown that it’s safe and works in older children and adults with B-lineage ALL after intensive chemotherapy, but until now the approach hadn’t been tested in infants, the investigators said.
The 30 subjects in the study were under a year old and newly diagnosed with KMT2A-rearranged ALL. They were treated with the Interfant-06 chemotherapy regimen – cytosine arabinoside and other agents – plus one postinduction course of blinatumomab at 15 micrograms/m2 per day as a 4-week continuous infusion. Eight of nine high-risk patients had allogeneic hematopoietic stem cell transplants.
Overall survival was 93.3% over a median follow up of 26.3 months, substantially higher than the 65.8% in the Interfant-06 trial. Two-year disease-free survival was 81.6% versus 49.4% in Interfant-06.
Sixteen patients (53%) were MRD negative after blinatumomab infusion and 12 (40%) had low levels of MRD. All of the children who continued chemotherapy went on to become MRD negative.
There were no permanent blinatumomab discontinuations and no treatment related deaths. Serious toxic effects were consistent with those in older patients and included four fevers, four infections, and one case each of hypertension and vomiting.
There were no cases of severe cytokine release syndrome (CRS) because of the low tumor burden of the subjects. Likewise, there were no obvious neurologic adverse events – like CRS, a particular concern with blinatumomab – but “we cannot rule out underreporting of mild neurologic symptoms that may have been unrecognized in infants,” the investigators said.
Patients who relapsed in the study had CNS involvement at relapse. “This underscores the need for adequate intrathecal chemotherapy during the blinatumomab infusion, because the efficacy of blinatumomab for the treatment of CNS leukemia may be limited,” they said.
The work was supported by Amgen, the maker of blinatumomab, as well as the Princess Maxima Center Foundation, the Danish Childhood Cancer Foundation, and others. Dr. Sluis is a consultant and researcher for Amgen. Five other authors were also consultants/advisers/researchers for the company. Dr. Sharma and Dr. Patel didn’t have any relevant disclosures.
.
Two-year disease-free and overall survival measures, as well as the percentage of children who had complete minimal residual disease (MRD) responses, were substantially higher among the 30 infants in the study than in historical controls treated with the same chemotherapy backbone in an earlier trial, Interfant-06.
“These outcome data are very promising, given the poor survival and lack of improvements in outcomes among infants with KMT2A-rearranged ALL in recent decades,” said the investigators, led by Inge M. van der Sluis, MD, PhD, a hematologist-oncologist at Princess Maxima Center for Pediatric Oncology in Utrecht, the Netherlands.
“The low incidence of relapse after treatment with blinatumomab is remarkable, given that in historical controls relapses occur frequently and early during therapy,” the investigators stated. Although the “follow-up time was relatively short” in the study, “it included the period historically defined” as being at high risk of relapse, they said.
The team suggested that future research should assess whether infants benefit from multiple courses of blinatumomab, rather than the one course used in the study, and whether blinatumomab plus chemotherapy can replace stem cell transplants for high-risk infants.
Pediatric community responds
There was excitement on Twitter about the results; a number of pediatric blood cancer specialists were impressed and posted the study on that platform. Comments included, “Wow! After years of stagnation, a huge step forward for infant leukemia” and “great news for infant lymphoblastic leukemia.”
Akshay Sharma, MBBS, a pediatric bone marrow transplant and cellular therapy specialist at St. Jude Children’s Research Hospital, Memphis, also posted. He said in an interview that the findings are “very exciting.”
The “outcomes of children diagnosed with leukemia in their infancy, particularly if they have a KMT2A rearrangement, have been dismal. This is terrific progress and a testament to the role that immunotherapy and novel agents will be playing in treatment of several malignant diseases in the decade to come,” he said.
Another poster, Pratik “Tik” Patel, MD, a pediatric hematology/oncology fellow at Emory University in Atlanta, told this news organization that the study “is welcome news to pediatric oncologists” and highlights “the success in incorporating newer immune-based therapeutics upfront in treatment rather than in relapsed/refractory settings.”
The National Cancer Institute–funded Children’s Oncology Group is thinking the same way. The group is launching a large, randomized trial to test if adding blinatumomab to chemotherapy upfront for B-cell acute lymphoblastic leukemia and lymphoblastic lymphoma improves outcomes in children and young adults aged 1-31 years. Results are due after 2029.
Study details
Blinatumomab is an expensive “T-cell engager” that helps cytotoxic CD3+T cells link to and destroy leukemic CD19+ B cells. Past studies have shown that it’s safe and works in older children and adults with B-lineage ALL after intensive chemotherapy, but until now the approach hadn’t been tested in infants, the investigators said.
The 30 subjects in the study were under a year old and newly diagnosed with KMT2A-rearranged ALL. They were treated with the Interfant-06 chemotherapy regimen – cytosine arabinoside and other agents – plus one postinduction course of blinatumomab at 15 micrograms/m2 per day as a 4-week continuous infusion. Eight of nine high-risk patients had allogeneic hematopoietic stem cell transplants.
Overall survival was 93.3% over a median follow up of 26.3 months, substantially higher than the 65.8% in the Interfant-06 trial. Two-year disease-free survival was 81.6% versus 49.4% in Interfant-06.
Sixteen patients (53%) were MRD negative after blinatumomab infusion and 12 (40%) had low levels of MRD. All of the children who continued chemotherapy went on to become MRD negative.
There were no permanent blinatumomab discontinuations and no treatment related deaths. Serious toxic effects were consistent with those in older patients and included four fevers, four infections, and one case each of hypertension and vomiting.
There were no cases of severe cytokine release syndrome (CRS) because of the low tumor burden of the subjects. Likewise, there were no obvious neurologic adverse events – like CRS, a particular concern with blinatumomab – but “we cannot rule out underreporting of mild neurologic symptoms that may have been unrecognized in infants,” the investigators said.
Patients who relapsed in the study had CNS involvement at relapse. “This underscores the need for adequate intrathecal chemotherapy during the blinatumomab infusion, because the efficacy of blinatumomab for the treatment of CNS leukemia may be limited,” they said.
The work was supported by Amgen, the maker of blinatumomab, as well as the Princess Maxima Center Foundation, the Danish Childhood Cancer Foundation, and others. Dr. Sluis is a consultant and researcher for Amgen. Five other authors were also consultants/advisers/researchers for the company. Dr. Sharma and Dr. Patel didn’t have any relevant disclosures.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Survey reveals room for improvement in teen substance use screening
WASHINGTON – , Deepa Camenga, MD, said in a presentation at the 2023 Pediatric Academic Societies annual meeting.
The American Academy of Pediatrics recommends universal screening for substance use in adolescents during annual health visits, but current screening rates and practices among primary care pediatricians in the United States are unknown, said Dr. Camenga, an associate professor at Yale University, New Haven, Conn.
Uniformity in screening is lacking
Dr. Camenga presented data from the 2021 AAP Periodic Survey, which included 1,683 nonretired AAP members in the United States. Residents were excluded. The current analysis included 471 pediatricians who reported providing health supervision to adolescents. Overall, 284 of the 471 included respondents (60%) reported always screening adolescent patients for substance use during a health supervision visit. Of these, 42% reported using a standardized screening instrument, Dr. Camenga said.
The majority (70%) of pediatricians who used a standardized screening tool opted for the CRAFFT tool (Car, Relax, Alone, Forget, Friends, Trouble) designed for ages 12-21 years. Another 21% reported using an unspecified screening tool, 4% used RAAPS (Rapid Assessment for Adolescent Preventive Services), 3% used S2BI (Screening to Brief Intervention), and 1% used BSTAD (Brief Screener for Tobacco, Alcohol, and other Drugs).
A total of 77% of respondents reported screening their adolescent patients for substance use without a parent or guardian present. Approximately half (52%) used paper-based screening, 22% used electronic screening, 21% used verbal screening, and 6% reported other methods.
A total of 68% and 70% of respondents, respectively, agreed or strongly agreed that top barriers to screening were the lack of an onsite provider for counseling and the lack of readily available treatment options. Other reported barriers included lack of knowledge or information, patient reluctance to discuss substance use, too many other priorities during the visit, and inadequate payment. Only 6% of respondents strongly agreed that lack of time was a barrier, said Dr. Camenga.
Screening frequency and screening practices varied by geographic region, Dr. Camenga said. Pediatricians in the South and Midwest were only half as likely as those in the Northeast to report always screening adolescents for substance use (adjusted odds ratio, 0.43 and 0.53, respectively; P < .05). Similarly, compared with pediatricians in the Northeast, those in the South, Midwest, and West were significantly less likely to report using a standardized instrument for substance use screening (aOR, 0.53, 0.24, and 0.52, respectively; P < 0.001 for all).
The disparities in screening by geographic region show that there is room for improvement in this area, said Dr. Camenga. Systems-level interventions such as treatment financing and access to telehealth services could improve primary care access to substance use treatment professionals, she said.
At the practice level, embedding screening and referral tools into electronic health records could potentially improve screening rates. Many primary care pediatricians do not receive training in identifying and assessing substance use in their patients, or in first-line treatment, Dr. Camenga said.
“We have to invest in a ‘train the trainer’ type of model,” she emphasized.
Data highlight regional resource gaps
The current study is important because it highlights potential missed opportunities to screen adolescents for substance use, said Sarah Yale, MD, assistant professor of pediatrics at the Medical College of Wisconsin, Milwaukee, in an interview. Dr. Yale said that the disparities in screening by region are interesting and should serve as a focus for resource investment because the lack of specialists for referral and treatment options in these areas is likely a contributing factor.
However, lack of training also plays a role, said Dr. Yale, who was not involved in the study but served as a moderator of the presentation session at the meeting. Many pediatricians in practice have not been trained in substance use screening, and the fact that many of those who did try to screen were not using a standardized screening tool indicates a need for provider education, she said. The take-home message for clinicians is to find ways to include substance use screening in the care of their adolescent patients. Additionally, more research is needed to assess how best to integrate screening tools into visits, whether on paper, electronically, or verbally, and to include training on substance use screening during pediatric medical training.
The survey was conducted by the American Academy of Pediatrics Research Division. This year’s survey was supported by the Conrad N. Hilton Foundation. Dr. Camenga had no financial conflicts to disclose. Dr. Yale had no financial conflicts to disclose.
WASHINGTON – , Deepa Camenga, MD, said in a presentation at the 2023 Pediatric Academic Societies annual meeting.
The American Academy of Pediatrics recommends universal screening for substance use in adolescents during annual health visits, but current screening rates and practices among primary care pediatricians in the United States are unknown, said Dr. Camenga, an associate professor at Yale University, New Haven, Conn.
Uniformity in screening is lacking
Dr. Camenga presented data from the 2021 AAP Periodic Survey, which included 1,683 nonretired AAP members in the United States. Residents were excluded. The current analysis included 471 pediatricians who reported providing health supervision to adolescents. Overall, 284 of the 471 included respondents (60%) reported always screening adolescent patients for substance use during a health supervision visit. Of these, 42% reported using a standardized screening instrument, Dr. Camenga said.
The majority (70%) of pediatricians who used a standardized screening tool opted for the CRAFFT tool (Car, Relax, Alone, Forget, Friends, Trouble) designed for ages 12-21 years. Another 21% reported using an unspecified screening tool, 4% used RAAPS (Rapid Assessment for Adolescent Preventive Services), 3% used S2BI (Screening to Brief Intervention), and 1% used BSTAD (Brief Screener for Tobacco, Alcohol, and other Drugs).
A total of 77% of respondents reported screening their adolescent patients for substance use without a parent or guardian present. Approximately half (52%) used paper-based screening, 22% used electronic screening, 21% used verbal screening, and 6% reported other methods.
A total of 68% and 70% of respondents, respectively, agreed or strongly agreed that top barriers to screening were the lack of an onsite provider for counseling and the lack of readily available treatment options. Other reported barriers included lack of knowledge or information, patient reluctance to discuss substance use, too many other priorities during the visit, and inadequate payment. Only 6% of respondents strongly agreed that lack of time was a barrier, said Dr. Camenga.
Screening frequency and screening practices varied by geographic region, Dr. Camenga said. Pediatricians in the South and Midwest were only half as likely as those in the Northeast to report always screening adolescents for substance use (adjusted odds ratio, 0.43 and 0.53, respectively; P < .05). Similarly, compared with pediatricians in the Northeast, those in the South, Midwest, and West were significantly less likely to report using a standardized instrument for substance use screening (aOR, 0.53, 0.24, and 0.52, respectively; P < 0.001 for all).
The disparities in screening by geographic region show that there is room for improvement in this area, said Dr. Camenga. Systems-level interventions such as treatment financing and access to telehealth services could improve primary care access to substance use treatment professionals, she said.
At the practice level, embedding screening and referral tools into electronic health records could potentially improve screening rates. Many primary care pediatricians do not receive training in identifying and assessing substance use in their patients, or in first-line treatment, Dr. Camenga said.
“We have to invest in a ‘train the trainer’ type of model,” she emphasized.
Data highlight regional resource gaps
The current study is important because it highlights potential missed opportunities to screen adolescents for substance use, said Sarah Yale, MD, assistant professor of pediatrics at the Medical College of Wisconsin, Milwaukee, in an interview. Dr. Yale said that the disparities in screening by region are interesting and should serve as a focus for resource investment because the lack of specialists for referral and treatment options in these areas is likely a contributing factor.
However, lack of training also plays a role, said Dr. Yale, who was not involved in the study but served as a moderator of the presentation session at the meeting. Many pediatricians in practice have not been trained in substance use screening, and the fact that many of those who did try to screen were not using a standardized screening tool indicates a need for provider education, she said. The take-home message for clinicians is to find ways to include substance use screening in the care of their adolescent patients. Additionally, more research is needed to assess how best to integrate screening tools into visits, whether on paper, electronically, or verbally, and to include training on substance use screening during pediatric medical training.
The survey was conducted by the American Academy of Pediatrics Research Division. This year’s survey was supported by the Conrad N. Hilton Foundation. Dr. Camenga had no financial conflicts to disclose. Dr. Yale had no financial conflicts to disclose.
WASHINGTON – , Deepa Camenga, MD, said in a presentation at the 2023 Pediatric Academic Societies annual meeting.
The American Academy of Pediatrics recommends universal screening for substance use in adolescents during annual health visits, but current screening rates and practices among primary care pediatricians in the United States are unknown, said Dr. Camenga, an associate professor at Yale University, New Haven, Conn.
Uniformity in screening is lacking
Dr. Camenga presented data from the 2021 AAP Periodic Survey, which included 1,683 nonretired AAP members in the United States. Residents were excluded. The current analysis included 471 pediatricians who reported providing health supervision to adolescents. Overall, 284 of the 471 included respondents (60%) reported always screening adolescent patients for substance use during a health supervision visit. Of these, 42% reported using a standardized screening instrument, Dr. Camenga said.
The majority (70%) of pediatricians who used a standardized screening tool opted for the CRAFFT tool (Car, Relax, Alone, Forget, Friends, Trouble) designed for ages 12-21 years. Another 21% reported using an unspecified screening tool, 4% used RAAPS (Rapid Assessment for Adolescent Preventive Services), 3% used S2BI (Screening to Brief Intervention), and 1% used BSTAD (Brief Screener for Tobacco, Alcohol, and other Drugs).
A total of 77% of respondents reported screening their adolescent patients for substance use without a parent or guardian present. Approximately half (52%) used paper-based screening, 22% used electronic screening, 21% used verbal screening, and 6% reported other methods.
A total of 68% and 70% of respondents, respectively, agreed or strongly agreed that top barriers to screening were the lack of an onsite provider for counseling and the lack of readily available treatment options. Other reported barriers included lack of knowledge or information, patient reluctance to discuss substance use, too many other priorities during the visit, and inadequate payment. Only 6% of respondents strongly agreed that lack of time was a barrier, said Dr. Camenga.
Screening frequency and screening practices varied by geographic region, Dr. Camenga said. Pediatricians in the South and Midwest were only half as likely as those in the Northeast to report always screening adolescents for substance use (adjusted odds ratio, 0.43 and 0.53, respectively; P < .05). Similarly, compared with pediatricians in the Northeast, those in the South, Midwest, and West were significantly less likely to report using a standardized instrument for substance use screening (aOR, 0.53, 0.24, and 0.52, respectively; P < 0.001 for all).
The disparities in screening by geographic region show that there is room for improvement in this area, said Dr. Camenga. Systems-level interventions such as treatment financing and access to telehealth services could improve primary care access to substance use treatment professionals, she said.
At the practice level, embedding screening and referral tools into electronic health records could potentially improve screening rates. Many primary care pediatricians do not receive training in identifying and assessing substance use in their patients, or in first-line treatment, Dr. Camenga said.
“We have to invest in a ‘train the trainer’ type of model,” she emphasized.
Data highlight regional resource gaps
The current study is important because it highlights potential missed opportunities to screen adolescents for substance use, said Sarah Yale, MD, assistant professor of pediatrics at the Medical College of Wisconsin, Milwaukee, in an interview. Dr. Yale said that the disparities in screening by region are interesting and should serve as a focus for resource investment because the lack of specialists for referral and treatment options in these areas is likely a contributing factor.
However, lack of training also plays a role, said Dr. Yale, who was not involved in the study but served as a moderator of the presentation session at the meeting. Many pediatricians in practice have not been trained in substance use screening, and the fact that many of those who did try to screen were not using a standardized screening tool indicates a need for provider education, she said. The take-home message for clinicians is to find ways to include substance use screening in the care of their adolescent patients. Additionally, more research is needed to assess how best to integrate screening tools into visits, whether on paper, electronically, or verbally, and to include training on substance use screening during pediatric medical training.
The survey was conducted by the American Academy of Pediatrics Research Division. This year’s survey was supported by the Conrad N. Hilton Foundation. Dr. Camenga had no financial conflicts to disclose. Dr. Yale had no financial conflicts to disclose.
AT PAS 2023
