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Darker Skin Tones Underrepresented on Skin Cancer Education Websites
“Given the known disparities patients with darker skin tones face in terms of increased skin cancer morbidity and mortality, this lack of representation further disadvantages those patients by not providing them with an adequate representation of how skin cancers manifest on their skin tones,” the study’s first author, Alana Sadur, who recently completed her third year at the George Washington School of Medicine and Health Sciences, Washington, said in an interview. “By not having images to refer to, patients are less likely to self-identify and seek treatment for concerning skin lesions.”
For the study, which was published in Journal of Drugs in Dermatology, Ms. Sadur and coauthors evaluated the inclusivity and representation of skin tones in photos of skin cancer on the following patient-facing websites: CDC.gov, NIH.gov, skincancer.org, americancancerfund.org, mayoclinic.org, and cancer.org. The researchers counted each individual person or image showing skin as a separate representation, and three independent reviewers used the 5-color Pantone swatch as described in a dermatology atlas to categorize representations as “lighter-toned skin” (Pantones A-B or lighter) or “darker-toned skin” (Pantones C-E or darker).
Of the 372 total representations identified on the websites, only 49 (13.2%) showed darker skin tones. Of these, 44.9% depicted Pantone C, 34.7% depicted Pantone D, and 20.4% depicted Pantone E. The researchers also found that only 11% of nonmelanoma skin cancers (NMSC) and 5.8% of melanoma skin cancers (MSC) were shown on darker skin tones, while no cartoon portrayals of NMSC or MSC included darker skin tones.
In findings related to nondisease representations on the websites, darker skin tones were depicted in just 22.7% of stock photos and 26.1% of website front pages.
The study’s senior author, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, emphasized the need for trusted sources like national organizations and federally funded agencies to be purposeful with their selection of images to “ensure all visitors to the site are represented,” he told this news organization.
“This is very important when dealing with skin cancer as a lack of representation could easily be misinterpreted as epidemiological data, meaning this gap could suggest certain individuals do not get skin cancer because photos in those skin tones are not present,” he added. “This doesn’t even begin to touch upon the diversity of individuals in the stock photos or lack thereof, which can perpetuate the lack of diversity in our specialty. We need to do better.”
The authors reported having no relevant disclosures.
A version of this article first appeared on Medscape.com.
“Given the known disparities patients with darker skin tones face in terms of increased skin cancer morbidity and mortality, this lack of representation further disadvantages those patients by not providing them with an adequate representation of how skin cancers manifest on their skin tones,” the study’s first author, Alana Sadur, who recently completed her third year at the George Washington School of Medicine and Health Sciences, Washington, said in an interview. “By not having images to refer to, patients are less likely to self-identify and seek treatment for concerning skin lesions.”
For the study, which was published in Journal of Drugs in Dermatology, Ms. Sadur and coauthors evaluated the inclusivity and representation of skin tones in photos of skin cancer on the following patient-facing websites: CDC.gov, NIH.gov, skincancer.org, americancancerfund.org, mayoclinic.org, and cancer.org. The researchers counted each individual person or image showing skin as a separate representation, and three independent reviewers used the 5-color Pantone swatch as described in a dermatology atlas to categorize representations as “lighter-toned skin” (Pantones A-B or lighter) or “darker-toned skin” (Pantones C-E or darker).
Of the 372 total representations identified on the websites, only 49 (13.2%) showed darker skin tones. Of these, 44.9% depicted Pantone C, 34.7% depicted Pantone D, and 20.4% depicted Pantone E. The researchers also found that only 11% of nonmelanoma skin cancers (NMSC) and 5.8% of melanoma skin cancers (MSC) were shown on darker skin tones, while no cartoon portrayals of NMSC or MSC included darker skin tones.
In findings related to nondisease representations on the websites, darker skin tones were depicted in just 22.7% of stock photos and 26.1% of website front pages.
The study’s senior author, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, emphasized the need for trusted sources like national organizations and federally funded agencies to be purposeful with their selection of images to “ensure all visitors to the site are represented,” he told this news organization.
“This is very important when dealing with skin cancer as a lack of representation could easily be misinterpreted as epidemiological data, meaning this gap could suggest certain individuals do not get skin cancer because photos in those skin tones are not present,” he added. “This doesn’t even begin to touch upon the diversity of individuals in the stock photos or lack thereof, which can perpetuate the lack of diversity in our specialty. We need to do better.”
The authors reported having no relevant disclosures.
A version of this article first appeared on Medscape.com.
“Given the known disparities patients with darker skin tones face in terms of increased skin cancer morbidity and mortality, this lack of representation further disadvantages those patients by not providing them with an adequate representation of how skin cancers manifest on their skin tones,” the study’s first author, Alana Sadur, who recently completed her third year at the George Washington School of Medicine and Health Sciences, Washington, said in an interview. “By not having images to refer to, patients are less likely to self-identify and seek treatment for concerning skin lesions.”
For the study, which was published in Journal of Drugs in Dermatology, Ms. Sadur and coauthors evaluated the inclusivity and representation of skin tones in photos of skin cancer on the following patient-facing websites: CDC.gov, NIH.gov, skincancer.org, americancancerfund.org, mayoclinic.org, and cancer.org. The researchers counted each individual person or image showing skin as a separate representation, and three independent reviewers used the 5-color Pantone swatch as described in a dermatology atlas to categorize representations as “lighter-toned skin” (Pantones A-B or lighter) or “darker-toned skin” (Pantones C-E or darker).
Of the 372 total representations identified on the websites, only 49 (13.2%) showed darker skin tones. Of these, 44.9% depicted Pantone C, 34.7% depicted Pantone D, and 20.4% depicted Pantone E. The researchers also found that only 11% of nonmelanoma skin cancers (NMSC) and 5.8% of melanoma skin cancers (MSC) were shown on darker skin tones, while no cartoon portrayals of NMSC or MSC included darker skin tones.
In findings related to nondisease representations on the websites, darker skin tones were depicted in just 22.7% of stock photos and 26.1% of website front pages.
The study’s senior author, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, emphasized the need for trusted sources like national organizations and federally funded agencies to be purposeful with their selection of images to “ensure all visitors to the site are represented,” he told this news organization.
“This is very important when dealing with skin cancer as a lack of representation could easily be misinterpreted as epidemiological data, meaning this gap could suggest certain individuals do not get skin cancer because photos in those skin tones are not present,” he added. “This doesn’t even begin to touch upon the diversity of individuals in the stock photos or lack thereof, which can perpetuate the lack of diversity in our specialty. We need to do better.”
The authors reported having no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM JOURNAL OF DRUGS IN DERMATOLOGY
Throbbing headache and nausea
Migraine is a form of recurrent headache that can present as migraine with aura or migraine without aura, with the latter being the most common form. As in this patient, migraine without aura is a chronic form of headache of moderate to severe intensity that usually lasts for several hours but rarely may persist for up to 3 days. Headache pain is unilateral and often aggravated by triggers such as routine physical activity. The American Headache Society diagnostic criteria for migraine without aura include having symptoms of nausea and/or hypersensitivity to light or sound. This patient also described symptoms typical of the prodromal phase of migraine, which include yawning, temperature control, excessive thirst, and mood swings.
Patients who have migraine with aura also have unilateral headache pain of several hours' duration but experience visual (eg, dots or flashes) or sensory (prickly sensation on skin) symptoms, or may have brief difficulty with speech or motor function. These aura symptoms generally last 5 to 60 minutes before abating.
The worldwide impact of migraine potentially reaches a billion individuals. Its prevalence is second only to tension-type headaches. Migraine occurs in patients of all ages and affects women at a rate two to three times higher than in men. Prevalence appears to peak in the third and fourth decades of life and tends to be lower among older adults. Migraine also has a negative effect on patients' work, school, or social lives, and is associated with increased rates of depression and anxiety in adults. For patients who are prone to migraines, potential triggers include some foods and beverages (including those that contain caffeine and alcohol), menstrual cycles in women, exposure to strobing or bright lights or loud sounds, stressful situations, extra physical activity, and too much or too little sleep.
Migraine is a clinical diagnosis based on number of headaches (five or more episodes) plus two or more of the characteristic signs (unilateral, throbbing pain, pain intensity of ≥ 5 on a 10-point scale, and pain aggravated by routine physical motion, such as climbing stairs or bending over) plus nausea and/or photosensitivity or phonosensitivity. Prodrome symptoms are reported by about 70% of adult patients. Diagnosis rarely requires neuroimaging; however, before prescribing medication, a complete lab and metabolic workup should be done.
Management of migraine without aura includes acute and preventive interventions. Acute interventions cited by the American Headache Society include nonsteroidal anti-inflammatory drugs and acetaminophen for mild pain, and migraine-specific therapies such as the triptans, ergotamine derivatives, gepants (rimegepant, ubrogepant), and lasmiditan. Because response to any of these therapies will differ among patients with migraine, shared decision-making with patients about benefits and potential side effects is necessary and should include flexibility to change therapy if needed.
Preventive therapy should be offered to patients experiencing six or more migraines a month (regardless of impairment) and those, like this patient, with three or more migraines a month that significantly impair daily activities. Preventive therapy can be considered for those with fewer monthly episodes, depending on the degree of impairment. Oral preventive therapies with established efficacy include candesartan, certain beta-blockers, topiramate, and valproate. Parenteral monoclonal antibodies that inhibit calcitonin gene-related peptide activity (eptinezumab, erenumab, fremanezumab, and galcanezumab) and onabotulinumtoxinA may be considered if oral therapies provide inadequate prevention.
Tension-type headache is the most common form of primary headache. These headaches are bilateral and characterized by a pressing or dull sensation that is often mild in intensity. They are different from migraine in that they occur infrequently, lack sensory symptoms, and generally are of shorter duration (30 minutes to 24 hours). Fasting-related headache is characterized by diffuse, nonpulsating pain and is relieved with food.
Heidi Moawad, MD, Clinical Assistant Professor, Department of Medical Education, Case Western Reserve University School of Medicine, Cleveland, Ohio.
Heidi Moawad, MD, has disclosed no relevant financial relationships.
Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.
Migraine is a form of recurrent headache that can present as migraine with aura or migraine without aura, with the latter being the most common form. As in this patient, migraine without aura is a chronic form of headache of moderate to severe intensity that usually lasts for several hours but rarely may persist for up to 3 days. Headache pain is unilateral and often aggravated by triggers such as routine physical activity. The American Headache Society diagnostic criteria for migraine without aura include having symptoms of nausea and/or hypersensitivity to light or sound. This patient also described symptoms typical of the prodromal phase of migraine, which include yawning, temperature control, excessive thirst, and mood swings.
Patients who have migraine with aura also have unilateral headache pain of several hours' duration but experience visual (eg, dots or flashes) or sensory (prickly sensation on skin) symptoms, or may have brief difficulty with speech or motor function. These aura symptoms generally last 5 to 60 minutes before abating.
The worldwide impact of migraine potentially reaches a billion individuals. Its prevalence is second only to tension-type headaches. Migraine occurs in patients of all ages and affects women at a rate two to three times higher than in men. Prevalence appears to peak in the third and fourth decades of life and tends to be lower among older adults. Migraine also has a negative effect on patients' work, school, or social lives, and is associated with increased rates of depression and anxiety in adults. For patients who are prone to migraines, potential triggers include some foods and beverages (including those that contain caffeine and alcohol), menstrual cycles in women, exposure to strobing or bright lights or loud sounds, stressful situations, extra physical activity, and too much or too little sleep.
Migraine is a clinical diagnosis based on number of headaches (five or more episodes) plus two or more of the characteristic signs (unilateral, throbbing pain, pain intensity of ≥ 5 on a 10-point scale, and pain aggravated by routine physical motion, such as climbing stairs or bending over) plus nausea and/or photosensitivity or phonosensitivity. Prodrome symptoms are reported by about 70% of adult patients. Diagnosis rarely requires neuroimaging; however, before prescribing medication, a complete lab and metabolic workup should be done.
Management of migraine without aura includes acute and preventive interventions. Acute interventions cited by the American Headache Society include nonsteroidal anti-inflammatory drugs and acetaminophen for mild pain, and migraine-specific therapies such as the triptans, ergotamine derivatives, gepants (rimegepant, ubrogepant), and lasmiditan. Because response to any of these therapies will differ among patients with migraine, shared decision-making with patients about benefits and potential side effects is necessary and should include flexibility to change therapy if needed.
Preventive therapy should be offered to patients experiencing six or more migraines a month (regardless of impairment) and those, like this patient, with three or more migraines a month that significantly impair daily activities. Preventive therapy can be considered for those with fewer monthly episodes, depending on the degree of impairment. Oral preventive therapies with established efficacy include candesartan, certain beta-blockers, topiramate, and valproate. Parenteral monoclonal antibodies that inhibit calcitonin gene-related peptide activity (eptinezumab, erenumab, fremanezumab, and galcanezumab) and onabotulinumtoxinA may be considered if oral therapies provide inadequate prevention.
Tension-type headache is the most common form of primary headache. These headaches are bilateral and characterized by a pressing or dull sensation that is often mild in intensity. They are different from migraine in that they occur infrequently, lack sensory symptoms, and generally are of shorter duration (30 minutes to 24 hours). Fasting-related headache is characterized by diffuse, nonpulsating pain and is relieved with food.
Heidi Moawad, MD, Clinical Assistant Professor, Department of Medical Education, Case Western Reserve University School of Medicine, Cleveland, Ohio.
Heidi Moawad, MD, has disclosed no relevant financial relationships.
Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.
Migraine is a form of recurrent headache that can present as migraine with aura or migraine without aura, with the latter being the most common form. As in this patient, migraine without aura is a chronic form of headache of moderate to severe intensity that usually lasts for several hours but rarely may persist for up to 3 days. Headache pain is unilateral and often aggravated by triggers such as routine physical activity. The American Headache Society diagnostic criteria for migraine without aura include having symptoms of nausea and/or hypersensitivity to light or sound. This patient also described symptoms typical of the prodromal phase of migraine, which include yawning, temperature control, excessive thirst, and mood swings.
Patients who have migraine with aura also have unilateral headache pain of several hours' duration but experience visual (eg, dots or flashes) or sensory (prickly sensation on skin) symptoms, or may have brief difficulty with speech or motor function. These aura symptoms generally last 5 to 60 minutes before abating.
The worldwide impact of migraine potentially reaches a billion individuals. Its prevalence is second only to tension-type headaches. Migraine occurs in patients of all ages and affects women at a rate two to three times higher than in men. Prevalence appears to peak in the third and fourth decades of life and tends to be lower among older adults. Migraine also has a negative effect on patients' work, school, or social lives, and is associated with increased rates of depression and anxiety in adults. For patients who are prone to migraines, potential triggers include some foods and beverages (including those that contain caffeine and alcohol), menstrual cycles in women, exposure to strobing or bright lights or loud sounds, stressful situations, extra physical activity, and too much or too little sleep.
Migraine is a clinical diagnosis based on number of headaches (five or more episodes) plus two or more of the characteristic signs (unilateral, throbbing pain, pain intensity of ≥ 5 on a 10-point scale, and pain aggravated by routine physical motion, such as climbing stairs or bending over) plus nausea and/or photosensitivity or phonosensitivity. Prodrome symptoms are reported by about 70% of adult patients. Diagnosis rarely requires neuroimaging; however, before prescribing medication, a complete lab and metabolic workup should be done.
Management of migraine without aura includes acute and preventive interventions. Acute interventions cited by the American Headache Society include nonsteroidal anti-inflammatory drugs and acetaminophen for mild pain, and migraine-specific therapies such as the triptans, ergotamine derivatives, gepants (rimegepant, ubrogepant), and lasmiditan. Because response to any of these therapies will differ among patients with migraine, shared decision-making with patients about benefits and potential side effects is necessary and should include flexibility to change therapy if needed.
Preventive therapy should be offered to patients experiencing six or more migraines a month (regardless of impairment) and those, like this patient, with three or more migraines a month that significantly impair daily activities. Preventive therapy can be considered for those with fewer monthly episodes, depending on the degree of impairment. Oral preventive therapies with established efficacy include candesartan, certain beta-blockers, topiramate, and valproate. Parenteral monoclonal antibodies that inhibit calcitonin gene-related peptide activity (eptinezumab, erenumab, fremanezumab, and galcanezumab) and onabotulinumtoxinA may be considered if oral therapies provide inadequate prevention.
Tension-type headache is the most common form of primary headache. These headaches are bilateral and characterized by a pressing or dull sensation that is often mild in intensity. They are different from migraine in that they occur infrequently, lack sensory symptoms, and generally are of shorter duration (30 minutes to 24 hours). Fasting-related headache is characterized by diffuse, nonpulsating pain and is relieved with food.
Heidi Moawad, MD, Clinical Assistant Professor, Department of Medical Education, Case Western Reserve University School of Medicine, Cleveland, Ohio.
Heidi Moawad, MD, has disclosed no relevant financial relationships.
Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.
A 30-year-old female patient (140 lb and 5 ft 7 in; BMI 21.9) presents at the emergency department with a throbbing headache that began after dinner and was accompanied by queasy nausea. She reports immediately going to bed and sleeping through the night, but pain and other symptoms were still present in the morning. At this point, headache duration is approaching 15 hours. The patient describes the headache pain as throbbing and intense on the left side of her head.
The patient has a demanding job in advertising and often works very long hours on little sleep; this latest headache developed after working through the night before. When asked, she admits to feeling lethargic, yawning (to the point where coworkers commented), and experiencing intervals of excessive sweating earlier in the day before the headache emerged. The patient attributed these to being tired and hungry because of skipped meals since the previous night's dinner.
She has no history of cardiovascular or other chronic illness, and her blood pressure is within normal range. She describes having had about seven similar headaches of shorter duration, over the past 2 months; in each case, the headache led to a missed workday or having to leave work early and/or cancel social plans.
Want a healthy diet? Eat real food, GI physician advises
What exactly is a healthy diet?
Scott Ketover, MD, AGAF, FASGE, will be the first to admit that’s not an easy question to answer. “As much research and information as we have, we don’t really know what a healthy diet is,” said Dr. Ketover, president and CEO of MNGI Digestive Health in Minneapolis, Minnesota. He was recognized by AGA this year with the Distinguished Clinician Award in Private Practice.
When patients ask questions about a healthy diet, Dr. Ketover responds with a dose of common sense: “If it’s food that didn’t exist in the year 1900, don’t eat it.” Your grandmother’s apple pie is fine in moderation, he said, but the apple pie you get at the McDonald’s drive-through could sit on your shelf for 6 months and look the same.
That is not something you should eat, he emphasizes.
“I really do believe though, that what crosses our lips and gets into our GI tract really underlies our entire health. It’s just that we don’t have enough information yet to know how we can coach people in telling them: eat this, not that,” he added.
In an interview, Dr. Ketover spoke more about the link between the gut microbiome and health, and the young patient who inspired him to become a GI physician.
Q: Why did you choose GI?
Dr. Ketover: I was a medical student working on my pediatrics rotation at Children’s Minnesota (Minneapolis Pediatrics Hospital). A 17-year-old young man who had Crohn’s disease really turned this into my lifelong passion. The patient confided in me that when he was 11, he had an ileostomy. He wore an ileostomy bag for 6 years and kept it hidden from all his friends. He was petrified of their knowing. And he told me at the age of 17 that if he knew how hard it was going to be to keep that secret, he would’ve preferred to have died rather than have the ileostomy. That got me thinking a lot about Crohn’s disease, and certainly how it affects patients. It became a very motivating thing for me to be involved in something that could potentially prevent this situation for others.
Today, we have much better treatment for Crohn’s than we did 30 years ago. So that’s all a good thing.
Q: Wellness and therapeutic diets are a specific interest of yours. Can you talk about this?
Dr. Ketover: We talk about things like Cheetos, Twinkies — those are not real foods. I do direct patients to ‘think’ when they go to the grocery store. All the good stuff is in the perimeter of the store. When you walk down the aisles, it’s all the processed food with added chemicals. It’s hard to point at specific things though and say: this is bad for you, but we do know that we should eat real food as often as we can. And I think that will contribute to our knowledge and learning about the intestinal microbiome. Again, we’re really at the beginning of our infancy of this, even though there’s lots of probiotics and things out there that claim to make you healthier. We don’t really know yet. And it’s going to take more time.
Q: What role does diet play in improving the intestinal microbiome?
Dr. Ketover: When you look at people who are healthy and who have low incidence of chronic diseases or inflammatory conditions, obesity, cancer, we’re starting to study their microbiome to see how it differs from people who have those illnesses and conditions and try to understand what the different constituents are of the microbiome. And then the big question is: Okay, so once we know that, how do we take ‘the unhealthy microbiome’ and change it to the ‘healthy microbiome’?
The only method we currently have is fecal transplant for Clostridioides difficile. And that’s just not a feasible way to change the microbiome for most people.
Some studies are going on with this. There’s been laboratory studies done with lab animals that show that fecal transplant can reverse obesity.
Q: Describe your biggest practice-related challenge and what you are doing to address it.
Dr. Ketover: The biggest challenge these days for medical practices is the relationship with the payer world and prior authorization. Where we’ve seen the greatest impact of prior authorization, unfortunately, is in the Medicare Advantage programs. Payers receive money from the federal government on plans that they can better manage the patient on, rather than Medicare. That results in a tremendous amount of prior authorization.
I get particularly incensed when I see that a lot of payers are practicing medicine without a license and they’re not relying on the professionals who are actually in the exam room with patients and doing the history and physical examination to determine what is an appropriate course of diagnosis or therapy for a patient.
It comes around every January. We have patients who are stable on meds, then their insurance gets renewed and the pharmacy formulary changes. Patients stable on various therapies are either kicked off them, or we have to go through the prior authorization process again for the same patient for the umpteenth time to keep them on a stable therapy.
How do I address that? It’s in conversations with payers and policy makers. There’s a lot going on in Washington, talking about prior authorization. I’m not sure that non-practitioners fully feel the pain that it delivers to patients.
Q: What teacher or mentor had the greatest impact on you?
Dr. Ketover: Phillip M. Kibort, MD, the pediatric physician I worked with as a medical student who really turned me on to GI medicine. We worked together on several patients and I was able to develop an appreciation for the breadth and depth of GI-related abnormalities and diseases and therapies. And I really got excited by the spectrum of opportunity that I would have as a physician to help treat patients with GI illness.
Q: What would you do differently if you had a chance?
Dr. Ketover: I’d travel more both for work and for pleasure. I really enjoy my relationships that I’ve created with lots of other gastroenterologists as well as non-physicians around policy issues. I’m involved in a couple of national organizations that talk to politicians on Capitol Hill and at state houses about patient advocacy. I would have done more of that earlier in my career if I could have.
Q: What do you like to do in your free time?
Dr. Ketover: I like to run, bike, walk. I like being outside as much as possible and enjoy being active.
Lightning Round
Texting or talking?
Texting, very efficient
Favorite city in U.S. besides the one you live in?
Waikiki, Honolulu
Favorite breakfast?
Pancakes
Place you most want to travel to?
Australia and New Zealand
Favorite junk food?
Pretzels and ice cream
Favorite season?
Summer
How many cups of coffee do you drink per day?
2-3
If you weren’t a gastroenterologist, what would you be?
Public policy writer
Who inspires you?
My wife
Best Halloween costume you ever wore?
Cowboy
Favorite type of music?
Classic rock
Favorite movie genre?
Science fiction, space exploration
Cat person or dog person?
Dog
Favorite sport?
Football — to watch
What song do you have to sing along with when you hear it?
Bohemian Rhapsody
Introvert or extrovert?
Introvert
Optimist or pessimist?
Optimist
What exactly is a healthy diet?
Scott Ketover, MD, AGAF, FASGE, will be the first to admit that’s not an easy question to answer. “As much research and information as we have, we don’t really know what a healthy diet is,” said Dr. Ketover, president and CEO of MNGI Digestive Health in Minneapolis, Minnesota. He was recognized by AGA this year with the Distinguished Clinician Award in Private Practice.
When patients ask questions about a healthy diet, Dr. Ketover responds with a dose of common sense: “If it’s food that didn’t exist in the year 1900, don’t eat it.” Your grandmother’s apple pie is fine in moderation, he said, but the apple pie you get at the McDonald’s drive-through could sit on your shelf for 6 months and look the same.
That is not something you should eat, he emphasizes.
“I really do believe though, that what crosses our lips and gets into our GI tract really underlies our entire health. It’s just that we don’t have enough information yet to know how we can coach people in telling them: eat this, not that,” he added.
In an interview, Dr. Ketover spoke more about the link between the gut microbiome and health, and the young patient who inspired him to become a GI physician.
Q: Why did you choose GI?
Dr. Ketover: I was a medical student working on my pediatrics rotation at Children’s Minnesota (Minneapolis Pediatrics Hospital). A 17-year-old young man who had Crohn’s disease really turned this into my lifelong passion. The patient confided in me that when he was 11, he had an ileostomy. He wore an ileostomy bag for 6 years and kept it hidden from all his friends. He was petrified of their knowing. And he told me at the age of 17 that if he knew how hard it was going to be to keep that secret, he would’ve preferred to have died rather than have the ileostomy. That got me thinking a lot about Crohn’s disease, and certainly how it affects patients. It became a very motivating thing for me to be involved in something that could potentially prevent this situation for others.
Today, we have much better treatment for Crohn’s than we did 30 years ago. So that’s all a good thing.
Q: Wellness and therapeutic diets are a specific interest of yours. Can you talk about this?
Dr. Ketover: We talk about things like Cheetos, Twinkies — those are not real foods. I do direct patients to ‘think’ when they go to the grocery store. All the good stuff is in the perimeter of the store. When you walk down the aisles, it’s all the processed food with added chemicals. It’s hard to point at specific things though and say: this is bad for you, but we do know that we should eat real food as often as we can. And I think that will contribute to our knowledge and learning about the intestinal microbiome. Again, we’re really at the beginning of our infancy of this, even though there’s lots of probiotics and things out there that claim to make you healthier. We don’t really know yet. And it’s going to take more time.
Q: What role does diet play in improving the intestinal microbiome?
Dr. Ketover: When you look at people who are healthy and who have low incidence of chronic diseases or inflammatory conditions, obesity, cancer, we’re starting to study their microbiome to see how it differs from people who have those illnesses and conditions and try to understand what the different constituents are of the microbiome. And then the big question is: Okay, so once we know that, how do we take ‘the unhealthy microbiome’ and change it to the ‘healthy microbiome’?
The only method we currently have is fecal transplant for Clostridioides difficile. And that’s just not a feasible way to change the microbiome for most people.
Some studies are going on with this. There’s been laboratory studies done with lab animals that show that fecal transplant can reverse obesity.
Q: Describe your biggest practice-related challenge and what you are doing to address it.
Dr. Ketover: The biggest challenge these days for medical practices is the relationship with the payer world and prior authorization. Where we’ve seen the greatest impact of prior authorization, unfortunately, is in the Medicare Advantage programs. Payers receive money from the federal government on plans that they can better manage the patient on, rather than Medicare. That results in a tremendous amount of prior authorization.
I get particularly incensed when I see that a lot of payers are practicing medicine without a license and they’re not relying on the professionals who are actually in the exam room with patients and doing the history and physical examination to determine what is an appropriate course of diagnosis or therapy for a patient.
It comes around every January. We have patients who are stable on meds, then their insurance gets renewed and the pharmacy formulary changes. Patients stable on various therapies are either kicked off them, or we have to go through the prior authorization process again for the same patient for the umpteenth time to keep them on a stable therapy.
How do I address that? It’s in conversations with payers and policy makers. There’s a lot going on in Washington, talking about prior authorization. I’m not sure that non-practitioners fully feel the pain that it delivers to patients.
Q: What teacher or mentor had the greatest impact on you?
Dr. Ketover: Phillip M. Kibort, MD, the pediatric physician I worked with as a medical student who really turned me on to GI medicine. We worked together on several patients and I was able to develop an appreciation for the breadth and depth of GI-related abnormalities and diseases and therapies. And I really got excited by the spectrum of opportunity that I would have as a physician to help treat patients with GI illness.
Q: What would you do differently if you had a chance?
Dr. Ketover: I’d travel more both for work and for pleasure. I really enjoy my relationships that I’ve created with lots of other gastroenterologists as well as non-physicians around policy issues. I’m involved in a couple of national organizations that talk to politicians on Capitol Hill and at state houses about patient advocacy. I would have done more of that earlier in my career if I could have.
Q: What do you like to do in your free time?
Dr. Ketover: I like to run, bike, walk. I like being outside as much as possible and enjoy being active.
Lightning Round
Texting or talking?
Texting, very efficient
Favorite city in U.S. besides the one you live in?
Waikiki, Honolulu
Favorite breakfast?
Pancakes
Place you most want to travel to?
Australia and New Zealand
Favorite junk food?
Pretzels and ice cream
Favorite season?
Summer
How many cups of coffee do you drink per day?
2-3
If you weren’t a gastroenterologist, what would you be?
Public policy writer
Who inspires you?
My wife
Best Halloween costume you ever wore?
Cowboy
Favorite type of music?
Classic rock
Favorite movie genre?
Science fiction, space exploration
Cat person or dog person?
Dog
Favorite sport?
Football — to watch
What song do you have to sing along with when you hear it?
Bohemian Rhapsody
Introvert or extrovert?
Introvert
Optimist or pessimist?
Optimist
What exactly is a healthy diet?
Scott Ketover, MD, AGAF, FASGE, will be the first to admit that’s not an easy question to answer. “As much research and information as we have, we don’t really know what a healthy diet is,” said Dr. Ketover, president and CEO of MNGI Digestive Health in Minneapolis, Minnesota. He was recognized by AGA this year with the Distinguished Clinician Award in Private Practice.
When patients ask questions about a healthy diet, Dr. Ketover responds with a dose of common sense: “If it’s food that didn’t exist in the year 1900, don’t eat it.” Your grandmother’s apple pie is fine in moderation, he said, but the apple pie you get at the McDonald’s drive-through could sit on your shelf for 6 months and look the same.
That is not something you should eat, he emphasizes.
“I really do believe though, that what crosses our lips and gets into our GI tract really underlies our entire health. It’s just that we don’t have enough information yet to know how we can coach people in telling them: eat this, not that,” he added.
In an interview, Dr. Ketover spoke more about the link between the gut microbiome and health, and the young patient who inspired him to become a GI physician.
Q: Why did you choose GI?
Dr. Ketover: I was a medical student working on my pediatrics rotation at Children’s Minnesota (Minneapolis Pediatrics Hospital). A 17-year-old young man who had Crohn’s disease really turned this into my lifelong passion. The patient confided in me that when he was 11, he had an ileostomy. He wore an ileostomy bag for 6 years and kept it hidden from all his friends. He was petrified of their knowing. And he told me at the age of 17 that if he knew how hard it was going to be to keep that secret, he would’ve preferred to have died rather than have the ileostomy. That got me thinking a lot about Crohn’s disease, and certainly how it affects patients. It became a very motivating thing for me to be involved in something that could potentially prevent this situation for others.
Today, we have much better treatment for Crohn’s than we did 30 years ago. So that’s all a good thing.
Q: Wellness and therapeutic diets are a specific interest of yours. Can you talk about this?
Dr. Ketover: We talk about things like Cheetos, Twinkies — those are not real foods. I do direct patients to ‘think’ when they go to the grocery store. All the good stuff is in the perimeter of the store. When you walk down the aisles, it’s all the processed food with added chemicals. It’s hard to point at specific things though and say: this is bad for you, but we do know that we should eat real food as often as we can. And I think that will contribute to our knowledge and learning about the intestinal microbiome. Again, we’re really at the beginning of our infancy of this, even though there’s lots of probiotics and things out there that claim to make you healthier. We don’t really know yet. And it’s going to take more time.
Q: What role does diet play in improving the intestinal microbiome?
Dr. Ketover: When you look at people who are healthy and who have low incidence of chronic diseases or inflammatory conditions, obesity, cancer, we’re starting to study their microbiome to see how it differs from people who have those illnesses and conditions and try to understand what the different constituents are of the microbiome. And then the big question is: Okay, so once we know that, how do we take ‘the unhealthy microbiome’ and change it to the ‘healthy microbiome’?
The only method we currently have is fecal transplant for Clostridioides difficile. And that’s just not a feasible way to change the microbiome for most people.
Some studies are going on with this. There’s been laboratory studies done with lab animals that show that fecal transplant can reverse obesity.
Q: Describe your biggest practice-related challenge and what you are doing to address it.
Dr. Ketover: The biggest challenge these days for medical practices is the relationship with the payer world and prior authorization. Where we’ve seen the greatest impact of prior authorization, unfortunately, is in the Medicare Advantage programs. Payers receive money from the federal government on plans that they can better manage the patient on, rather than Medicare. That results in a tremendous amount of prior authorization.
I get particularly incensed when I see that a lot of payers are practicing medicine without a license and they’re not relying on the professionals who are actually in the exam room with patients and doing the history and physical examination to determine what is an appropriate course of diagnosis or therapy for a patient.
It comes around every January. We have patients who are stable on meds, then their insurance gets renewed and the pharmacy formulary changes. Patients stable on various therapies are either kicked off them, or we have to go through the prior authorization process again for the same patient for the umpteenth time to keep them on a stable therapy.
How do I address that? It’s in conversations with payers and policy makers. There’s a lot going on in Washington, talking about prior authorization. I’m not sure that non-practitioners fully feel the pain that it delivers to patients.
Q: What teacher or mentor had the greatest impact on you?
Dr. Ketover: Phillip M. Kibort, MD, the pediatric physician I worked with as a medical student who really turned me on to GI medicine. We worked together on several patients and I was able to develop an appreciation for the breadth and depth of GI-related abnormalities and diseases and therapies. And I really got excited by the spectrum of opportunity that I would have as a physician to help treat patients with GI illness.
Q: What would you do differently if you had a chance?
Dr. Ketover: I’d travel more both for work and for pleasure. I really enjoy my relationships that I’ve created with lots of other gastroenterologists as well as non-physicians around policy issues. I’m involved in a couple of national organizations that talk to politicians on Capitol Hill and at state houses about patient advocacy. I would have done more of that earlier in my career if I could have.
Q: What do you like to do in your free time?
Dr. Ketover: I like to run, bike, walk. I like being outside as much as possible and enjoy being active.
Lightning Round
Texting or talking?
Texting, very efficient
Favorite city in U.S. besides the one you live in?
Waikiki, Honolulu
Favorite breakfast?
Pancakes
Place you most want to travel to?
Australia and New Zealand
Favorite junk food?
Pretzels and ice cream
Favorite season?
Summer
How many cups of coffee do you drink per day?
2-3
If you weren’t a gastroenterologist, what would you be?
Public policy writer
Who inspires you?
My wife
Best Halloween costume you ever wore?
Cowboy
Favorite type of music?
Classic rock
Favorite movie genre?
Science fiction, space exploration
Cat person or dog person?
Dog
Favorite sport?
Football — to watch
What song do you have to sing along with when you hear it?
Bohemian Rhapsody
Introvert or extrovert?
Introvert
Optimist or pessimist?
Optimist
Myth of the Month: Is Contrast-Induced Acute Kidney Injury Real?
A 59-year-old man presents with abdominal pain. He has a history of small bowel obstruction and diverticulitis. His medical history includes chronic kidney disease (CKD; baseline creatinine, 1.8 mg/dL), hypertension, type 2 diabetes, and depression. He had a colectomy 6 years ago for colon cancer.
He takes the following medications: Semaglutide (1 mg weekly), amlodipine (5 mg once daily), and escitalopram (10 mg once daily). On physical exam his blood pressure is 130/80 mm Hg, his pulse is 90, and his temperature is 37.2 degrees C. He has normal bowel sounds but guarding in the right lower quadrant.
His hemoglobin is 14 g/dL, his blood sodium is 136 mEq/L, his blood potassium is 4.0 mmol/L, his BUN is 26 mg/dL, and his creatinine is 1.9 mg/dL. His kidney, ureter, bladder x-ray is unremarkable.
What imaging would you recommend?
A) CT without contrast
B) CT with contrast
C) MRI
D) Abdominal ultrasound
This patient has several potential causes for his abdominal pain that imaging may clarify. I think a contrast CT scan would be the most likely to provide helpful information. It is likely that if it were ordered, there may be hesitation by the radiologist to perform the scan with contrast because of the patient’s CKD.
Concern for contrast-induced kidney injury has limited diagnostic testing for many years. How strong is the evidence for contrast-induced kidney injury, and should we avoid testing that requires contrast in patients with CKD? McDonald and colleagues performed a meta-analysis with 13 studies meeting inclusion criteria, involving 25,950 patients.1 They found no increased risk of acute kidney injury (AKI) in patients who received contrast medium compared with those who did not receive contrast; relative risk of AKI for those receiving contrast was 0.79 (confidence interval: 0.62-1.02). Importantly, there was no difference in AKI in patients with diabetes or CKD.
Ehmann et al. looked at renal outcomes in patients who received IV contrast when they presented to an emergency department with AKI.2 They found that in patients with AKI, receiving contrast was not associated with persistent AKI at hospital discharge. Hinson and colleagues looked at patients arriving at the emergency department and needing imaging.3 They did a retrospective, cohort analysis of 17,934 patients who had CT with contrast, CT with no contrast, or no CT. Contrast administration was not associated with increased incidence of AKI (odds ratio, 0.96, CI: 0.85-1.08).
Aycock et al. did a meta-analysis of AKI after CT scanning, including 28 studies involving 107,335 patients.4 They found that compared with noncontrast CT, CT scanning with contrast was not associated with AKI (OR, 0.94, CI: 0.83-1.07). Elias and Aronson looked at the risk of AKI after contrast in patients receiving CT scans compared with those who received ventilation/perfusion scans to evaluate for pulmonary embolism.5 There were 44 AKI events (4.5%) in patients exposed to contrast media and 33 events (3.4%) in patients not exposed to contrast media (risk difference: 1.1%, 95% CI: -0.6% to 2.9%; OR, 1.39, CI: 0.86-2.26; P = .18).
Despite multiple studies showing no increased risk, there is still a concern that contrast can cause AKI.6 Animal models have shown iodinated contrast can have a deleterious effect on mitochondria and membrane function.6 Criticisms of the retrospective nature of many of the studies I have shared, and the lack of randomized, controlled trials are that there may be bias in these studies, as the highest-risk patients are the ones most likely not to receive contrast. In a joint guideline from the American College of Radiology and the National Kidney Foundation, this statement was made: “The risk of acute kidney injury developing in patients with reduced kidney function following exposure to intravenous iodinated contrast media has been overstated.”7 Their recommendation was to give contrast if needed in patients with glomerular filtration rates (GFRs) greater than 30.
Myth: Contrast-induced renal injury is a concern.
Clinical impact: For CT scanning, it is OK to give contrast when needed. A conservative cutoff for contrast use would be a GFR less than 30.
Dr. Paauw is professor of medicine in the Division of General Internal Medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].
References
1. McDonald JS et al. Radiology. 2013:267:119-128.
2. Ehmann MR et al. Intensive Care Med. 2023:49(2):205-215.
3. Hinson JS et al. Ann Emerg Med. 2017;69(5):577-586.
4. Aycock RD et al. Ann Emerg Med. 2018 Jan;71(1):44-53.
5. Elias A, Aronson D. Thromb Haemost. 2021 Jun;121(6):800-807.
6. Weisbord SD, du Cheryon D. Intensive Care Med. 2018;44(1):107-109.
7. Davenport MS et al. Radiology. 2020;294(3):660-668.
A 59-year-old man presents with abdominal pain. He has a history of small bowel obstruction and diverticulitis. His medical history includes chronic kidney disease (CKD; baseline creatinine, 1.8 mg/dL), hypertension, type 2 diabetes, and depression. He had a colectomy 6 years ago for colon cancer.
He takes the following medications: Semaglutide (1 mg weekly), amlodipine (5 mg once daily), and escitalopram (10 mg once daily). On physical exam his blood pressure is 130/80 mm Hg, his pulse is 90, and his temperature is 37.2 degrees C. He has normal bowel sounds but guarding in the right lower quadrant.
His hemoglobin is 14 g/dL, his blood sodium is 136 mEq/L, his blood potassium is 4.0 mmol/L, his BUN is 26 mg/dL, and his creatinine is 1.9 mg/dL. His kidney, ureter, bladder x-ray is unremarkable.
What imaging would you recommend?
A) CT without contrast
B) CT with contrast
C) MRI
D) Abdominal ultrasound
This patient has several potential causes for his abdominal pain that imaging may clarify. I think a contrast CT scan would be the most likely to provide helpful information. It is likely that if it were ordered, there may be hesitation by the radiologist to perform the scan with contrast because of the patient’s CKD.
Concern for contrast-induced kidney injury has limited diagnostic testing for many years. How strong is the evidence for contrast-induced kidney injury, and should we avoid testing that requires contrast in patients with CKD? McDonald and colleagues performed a meta-analysis with 13 studies meeting inclusion criteria, involving 25,950 patients.1 They found no increased risk of acute kidney injury (AKI) in patients who received contrast medium compared with those who did not receive contrast; relative risk of AKI for those receiving contrast was 0.79 (confidence interval: 0.62-1.02). Importantly, there was no difference in AKI in patients with diabetes or CKD.
Ehmann et al. looked at renal outcomes in patients who received IV contrast when they presented to an emergency department with AKI.2 They found that in patients with AKI, receiving contrast was not associated with persistent AKI at hospital discharge. Hinson and colleagues looked at patients arriving at the emergency department and needing imaging.3 They did a retrospective, cohort analysis of 17,934 patients who had CT with contrast, CT with no contrast, or no CT. Contrast administration was not associated with increased incidence of AKI (odds ratio, 0.96, CI: 0.85-1.08).
Aycock et al. did a meta-analysis of AKI after CT scanning, including 28 studies involving 107,335 patients.4 They found that compared with noncontrast CT, CT scanning with contrast was not associated with AKI (OR, 0.94, CI: 0.83-1.07). Elias and Aronson looked at the risk of AKI after contrast in patients receiving CT scans compared with those who received ventilation/perfusion scans to evaluate for pulmonary embolism.5 There were 44 AKI events (4.5%) in patients exposed to contrast media and 33 events (3.4%) in patients not exposed to contrast media (risk difference: 1.1%, 95% CI: -0.6% to 2.9%; OR, 1.39, CI: 0.86-2.26; P = .18).
Despite multiple studies showing no increased risk, there is still a concern that contrast can cause AKI.6 Animal models have shown iodinated contrast can have a deleterious effect on mitochondria and membrane function.6 Criticisms of the retrospective nature of many of the studies I have shared, and the lack of randomized, controlled trials are that there may be bias in these studies, as the highest-risk patients are the ones most likely not to receive contrast. In a joint guideline from the American College of Radiology and the National Kidney Foundation, this statement was made: “The risk of acute kidney injury developing in patients with reduced kidney function following exposure to intravenous iodinated contrast media has been overstated.”7 Their recommendation was to give contrast if needed in patients with glomerular filtration rates (GFRs) greater than 30.
Myth: Contrast-induced renal injury is a concern.
Clinical impact: For CT scanning, it is OK to give contrast when needed. A conservative cutoff for contrast use would be a GFR less than 30.
Dr. Paauw is professor of medicine in the Division of General Internal Medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].
References
1. McDonald JS et al. Radiology. 2013:267:119-128.
2. Ehmann MR et al. Intensive Care Med. 2023:49(2):205-215.
3. Hinson JS et al. Ann Emerg Med. 2017;69(5):577-586.
4. Aycock RD et al. Ann Emerg Med. 2018 Jan;71(1):44-53.
5. Elias A, Aronson D. Thromb Haemost. 2021 Jun;121(6):800-807.
6. Weisbord SD, du Cheryon D. Intensive Care Med. 2018;44(1):107-109.
7. Davenport MS et al. Radiology. 2020;294(3):660-668.
A 59-year-old man presents with abdominal pain. He has a history of small bowel obstruction and diverticulitis. His medical history includes chronic kidney disease (CKD; baseline creatinine, 1.8 mg/dL), hypertension, type 2 diabetes, and depression. He had a colectomy 6 years ago for colon cancer.
He takes the following medications: Semaglutide (1 mg weekly), amlodipine (5 mg once daily), and escitalopram (10 mg once daily). On physical exam his blood pressure is 130/80 mm Hg, his pulse is 90, and his temperature is 37.2 degrees C. He has normal bowel sounds but guarding in the right lower quadrant.
His hemoglobin is 14 g/dL, his blood sodium is 136 mEq/L, his blood potassium is 4.0 mmol/L, his BUN is 26 mg/dL, and his creatinine is 1.9 mg/dL. His kidney, ureter, bladder x-ray is unremarkable.
What imaging would you recommend?
A) CT without contrast
B) CT with contrast
C) MRI
D) Abdominal ultrasound
This patient has several potential causes for his abdominal pain that imaging may clarify. I think a contrast CT scan would be the most likely to provide helpful information. It is likely that if it were ordered, there may be hesitation by the radiologist to perform the scan with contrast because of the patient’s CKD.
Concern for contrast-induced kidney injury has limited diagnostic testing for many years. How strong is the evidence for contrast-induced kidney injury, and should we avoid testing that requires contrast in patients with CKD? McDonald and colleagues performed a meta-analysis with 13 studies meeting inclusion criteria, involving 25,950 patients.1 They found no increased risk of acute kidney injury (AKI) in patients who received contrast medium compared with those who did not receive contrast; relative risk of AKI for those receiving contrast was 0.79 (confidence interval: 0.62-1.02). Importantly, there was no difference in AKI in patients with diabetes or CKD.
Ehmann et al. looked at renal outcomes in patients who received IV contrast when they presented to an emergency department with AKI.2 They found that in patients with AKI, receiving contrast was not associated with persistent AKI at hospital discharge. Hinson and colleagues looked at patients arriving at the emergency department and needing imaging.3 They did a retrospective, cohort analysis of 17,934 patients who had CT with contrast, CT with no contrast, or no CT. Contrast administration was not associated with increased incidence of AKI (odds ratio, 0.96, CI: 0.85-1.08).
Aycock et al. did a meta-analysis of AKI after CT scanning, including 28 studies involving 107,335 patients.4 They found that compared with noncontrast CT, CT scanning with contrast was not associated with AKI (OR, 0.94, CI: 0.83-1.07). Elias and Aronson looked at the risk of AKI after contrast in patients receiving CT scans compared with those who received ventilation/perfusion scans to evaluate for pulmonary embolism.5 There were 44 AKI events (4.5%) in patients exposed to contrast media and 33 events (3.4%) in patients not exposed to contrast media (risk difference: 1.1%, 95% CI: -0.6% to 2.9%; OR, 1.39, CI: 0.86-2.26; P = .18).
Despite multiple studies showing no increased risk, there is still a concern that contrast can cause AKI.6 Animal models have shown iodinated contrast can have a deleterious effect on mitochondria and membrane function.6 Criticisms of the retrospective nature of many of the studies I have shared, and the lack of randomized, controlled trials are that there may be bias in these studies, as the highest-risk patients are the ones most likely not to receive contrast. In a joint guideline from the American College of Radiology and the National Kidney Foundation, this statement was made: “The risk of acute kidney injury developing in patients with reduced kidney function following exposure to intravenous iodinated contrast media has been overstated.”7 Their recommendation was to give contrast if needed in patients with glomerular filtration rates (GFRs) greater than 30.
Myth: Contrast-induced renal injury is a concern.
Clinical impact: For CT scanning, it is OK to give contrast when needed. A conservative cutoff for contrast use would be a GFR less than 30.
Dr. Paauw is professor of medicine in the Division of General Internal Medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].
References
1. McDonald JS et al. Radiology. 2013:267:119-128.
2. Ehmann MR et al. Intensive Care Med. 2023:49(2):205-215.
3. Hinson JS et al. Ann Emerg Med. 2017;69(5):577-586.
4. Aycock RD et al. Ann Emerg Med. 2018 Jan;71(1):44-53.
5. Elias A, Aronson D. Thromb Haemost. 2021 Jun;121(6):800-807.
6. Weisbord SD, du Cheryon D. Intensive Care Med. 2018;44(1):107-109.
7. Davenport MS et al. Radiology. 2020;294(3):660-668.
US Researchers Call for Robust Studies Into Dequalinium, a Bacterial Vaginosis Therapy Common in Europe
Interest is growing in a standard European treatment for bacterial vaginosis (BV).
In a commentary published in JAMA Network Open, researchers and doctors from the Johns Hopkins University School of Medicine in Baltimore and the University of Maryland, Baltimore, urged clinical trials in the United States to determine if dequalinium chloride — an antiseptic that inhibits the growth of bacteria and fungi — is on par with or better than treatments currently available.
Dequalinium has been used throughout Europe for decades and is recommended as an alternative or second-line BV treatment by the World Health Organization; the International Society for the Study of Vulvovaginal Disease; and the Austrian, German, Portuguese, Spanish, and Swiss Societies of Gynecology and Obstetrics. However, the product has not been approved for clinical use in the United States, no trials studying the drug have been registered on ClinicalTrials.gov, and the US Food and Drug Administration has not received an application for approval, according to agency records.
Treatments in the United States for BV include metronidazole and clindamycin that, while effective, have a recurrence rate of up to 60%.
“Current treatments for bacterial vaginosis often fall short, primarily due to frequent recurrences after treatment,” said Rebecca M. Brotman, PhD, MPH, a professor in the Department of Epidemiology and Public Health at the Institute for Genome Sciences at the University of Maryland School of Medicine, and the corresponding author of the commentary.
More than 40% of people with recurrent BV do not receive adequate treatment, according to Caroline M. Mitchell, MD, MPH, director of the Vulvovaginal Disorders Program at Massachusetts General Hospital Vincent Center for Reproductive Biology, Boston, Massachusetts.
“BV is very disruptive to people’s daily lives and causes significant distress,” said Dr. Mitchell, who was not a coauthor of the new article. “Additionally, BV is associated with higher risk for HPV [human papillomavirus] infection, progression of HPV to cervical dysplasia, as well as risk for acquisition of other sexually transmitted infections.”
Dr. Mitchell said she hopes a recent trial from Europe comparing dequalinium chloride to metronidazole spurs researchers to study its efficacy and safety among women in the United States.
“Dequalinium has some antifungal activity, so it might offer a lower chance of yeast infection after treatment, which is important because posttreatment vulvovaginal candidiasis is one of the downsides to conventional antibiotic treatments,” Dr. Mitchell said.
The recent clinical trial included 147 premenopausal women with BV who received 10 mg of dequalinium per day for 6 days or oral metronidazole (500 mg twice daily for 7 days).
Dr. Brotman said any studies in the United States would need to examine long-term recurrence of vaginosis after treatment with dequalinium chloride and its use during pregnancy.
The study was funded by various grants from the National Institutes of Health and the Gates Foundation. Various authors reported receiving royalties from UpToDate outside the submitted work or receiving a donation of sexually transmitted infection testing kits from Hologic for a study outside the submitted work. No other disclosures were reported.
A version of this article first appeared on Medscape.com.
Interest is growing in a standard European treatment for bacterial vaginosis (BV).
In a commentary published in JAMA Network Open, researchers and doctors from the Johns Hopkins University School of Medicine in Baltimore and the University of Maryland, Baltimore, urged clinical trials in the United States to determine if dequalinium chloride — an antiseptic that inhibits the growth of bacteria and fungi — is on par with or better than treatments currently available.
Dequalinium has been used throughout Europe for decades and is recommended as an alternative or second-line BV treatment by the World Health Organization; the International Society for the Study of Vulvovaginal Disease; and the Austrian, German, Portuguese, Spanish, and Swiss Societies of Gynecology and Obstetrics. However, the product has not been approved for clinical use in the United States, no trials studying the drug have been registered on ClinicalTrials.gov, and the US Food and Drug Administration has not received an application for approval, according to agency records.
Treatments in the United States for BV include metronidazole and clindamycin that, while effective, have a recurrence rate of up to 60%.
“Current treatments for bacterial vaginosis often fall short, primarily due to frequent recurrences after treatment,” said Rebecca M. Brotman, PhD, MPH, a professor in the Department of Epidemiology and Public Health at the Institute for Genome Sciences at the University of Maryland School of Medicine, and the corresponding author of the commentary.
More than 40% of people with recurrent BV do not receive adequate treatment, according to Caroline M. Mitchell, MD, MPH, director of the Vulvovaginal Disorders Program at Massachusetts General Hospital Vincent Center for Reproductive Biology, Boston, Massachusetts.
“BV is very disruptive to people’s daily lives and causes significant distress,” said Dr. Mitchell, who was not a coauthor of the new article. “Additionally, BV is associated with higher risk for HPV [human papillomavirus] infection, progression of HPV to cervical dysplasia, as well as risk for acquisition of other sexually transmitted infections.”
Dr. Mitchell said she hopes a recent trial from Europe comparing dequalinium chloride to metronidazole spurs researchers to study its efficacy and safety among women in the United States.
“Dequalinium has some antifungal activity, so it might offer a lower chance of yeast infection after treatment, which is important because posttreatment vulvovaginal candidiasis is one of the downsides to conventional antibiotic treatments,” Dr. Mitchell said.
The recent clinical trial included 147 premenopausal women with BV who received 10 mg of dequalinium per day for 6 days or oral metronidazole (500 mg twice daily for 7 days).
Dr. Brotman said any studies in the United States would need to examine long-term recurrence of vaginosis after treatment with dequalinium chloride and its use during pregnancy.
The study was funded by various grants from the National Institutes of Health and the Gates Foundation. Various authors reported receiving royalties from UpToDate outside the submitted work or receiving a donation of sexually transmitted infection testing kits from Hologic for a study outside the submitted work. No other disclosures were reported.
A version of this article first appeared on Medscape.com.
Interest is growing in a standard European treatment for bacterial vaginosis (BV).
In a commentary published in JAMA Network Open, researchers and doctors from the Johns Hopkins University School of Medicine in Baltimore and the University of Maryland, Baltimore, urged clinical trials in the United States to determine if dequalinium chloride — an antiseptic that inhibits the growth of bacteria and fungi — is on par with or better than treatments currently available.
Dequalinium has been used throughout Europe for decades and is recommended as an alternative or second-line BV treatment by the World Health Organization; the International Society for the Study of Vulvovaginal Disease; and the Austrian, German, Portuguese, Spanish, and Swiss Societies of Gynecology and Obstetrics. However, the product has not been approved for clinical use in the United States, no trials studying the drug have been registered on ClinicalTrials.gov, and the US Food and Drug Administration has not received an application for approval, according to agency records.
Treatments in the United States for BV include metronidazole and clindamycin that, while effective, have a recurrence rate of up to 60%.
“Current treatments for bacterial vaginosis often fall short, primarily due to frequent recurrences after treatment,” said Rebecca M. Brotman, PhD, MPH, a professor in the Department of Epidemiology and Public Health at the Institute for Genome Sciences at the University of Maryland School of Medicine, and the corresponding author of the commentary.
More than 40% of people with recurrent BV do not receive adequate treatment, according to Caroline M. Mitchell, MD, MPH, director of the Vulvovaginal Disorders Program at Massachusetts General Hospital Vincent Center for Reproductive Biology, Boston, Massachusetts.
“BV is very disruptive to people’s daily lives and causes significant distress,” said Dr. Mitchell, who was not a coauthor of the new article. “Additionally, BV is associated with higher risk for HPV [human papillomavirus] infection, progression of HPV to cervical dysplasia, as well as risk for acquisition of other sexually transmitted infections.”
Dr. Mitchell said she hopes a recent trial from Europe comparing dequalinium chloride to metronidazole spurs researchers to study its efficacy and safety among women in the United States.
“Dequalinium has some antifungal activity, so it might offer a lower chance of yeast infection after treatment, which is important because posttreatment vulvovaginal candidiasis is one of the downsides to conventional antibiotic treatments,” Dr. Mitchell said.
The recent clinical trial included 147 premenopausal women with BV who received 10 mg of dequalinium per day for 6 days or oral metronidazole (500 mg twice daily for 7 days).
Dr. Brotman said any studies in the United States would need to examine long-term recurrence of vaginosis after treatment with dequalinium chloride and its use during pregnancy.
The study was funded by various grants from the National Institutes of Health and the Gates Foundation. Various authors reported receiving royalties from UpToDate outside the submitted work or receiving a donation of sexually transmitted infection testing kits from Hologic for a study outside the submitted work. No other disclosures were reported.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Vibegron Seen Effective for Overactive Bladder in Men With BPH
The medication vibegron led to improvements in symptoms of overactive bladder and overall quality of life in men undergoing treatment for benign prostatic hyperplasia, according to findings from a phase 3 trial presented at the annual meeting of the American Urological Association (AUA) and data published in the Journal of Urology.
“Vibegron was associated with significant reductions in daily micturition and urgency episodes, as well as our secondary endpoints,” David R. Staskin, MD, an associate professor of urology at Tufts University School of Medicine in Boston, told attendees. “Symptoms really did improve compared to placebo as early as week 2.”
Vibegron is a selective beta-3 adrenergic receptor agonist approved in 2020 by the US Food and Drug Administration for the treatment of overactive bladder.
However, treating overactive bladder symptoms in patients undergoing benign prostatic hyperplasia treatment is more complex because benign prostatic hyperplasia itself can contribute to overactive bladder symptoms, said Kara Watts, MD, an associate professor of urology at Montefiore Einstein in New York City, who was not involved in the new research.
“Management of overactive bladder in this setting may require treatment of benign prostatic hyperplasia as well, but a discussion of the relationship between benign prostatic hyperplasia and overactive bladder symptoms is important,” Dr. Watts told this news organization. “Beyond consideration of treatment for benign prostatic hyperplasia — which can be in the form of medications or surgeries to reduce the size of the prostate — treatment of overactive bladder can include behavioral modification,” such as avoiding bladder irritants, timed voiding, managing constipation, and nighttime liquid restriction,” as well as “medications, percutaneous tibial nerve stimulation, and occasionally more invasive options.”
Vibegron “represents a very attractive and effective pharmaceutical management option for overactive bladder,” both in patients with and without benign prostatic hyperplasia, Dr. Watts said. “It has a favorable side-effect profile compared to other oral agents that can be prescribed for overactive bladder, such as anticholinergics, and also has the added benefit of a much lower risk of urinary retention in comparison to most other oral agents.”
Among 1104 men at least 45 years old who were undergoing treatment for benign prostatic hyperplasia and had symptoms of overactive bladder, 538 received 75 mg of vibegron and 542 received a placebo. The men in the vibegron group showed 2.04 fewer mean daily urinations at 12 weeks and 2.2 fewer at 24 weeks compared to 1.3 fewer at both 12 and 24 weeks for men in the placebo group (P < .0001), according to the researchers.
The drug also reduced urgency of urination. Mean daily episodes of urgency were 2.88 fewer at 12 weeks and 3.07 fewer at 24 weeks in the vibegron group compared to 1.93 and 2.17 fewer, respectively, in the placebo group (P < .0001).
In secondary endpoints, those taking vibegron experienced 0.22 fewer episodes of nocturia (P = .002), 0.8 fewer episodes of urgency incontinence (P = .003), a 0.9-point difference in improvement in the International Prostate Symptom Score (P < .0001), and about 15 mL more volume voided (P < .0001) compared to those receiving placebo, the researchers reported.
“The clinical significance of these findings is that vibegron represents an effective pharmacologic option for managing overactive bladder in the context of concomitant benign prostatic hyperplasia, which is a broader context than its original approval for overactive bladder alone,” Dr. Watts said.
Data from 969 patients on the overactive bladder quality-of-life questionnaire found that the symptom bother score was 6.2 points better for men in the vibegron group than those who took a placebo (P < .0001) at 12 weeks. Similarly, the total health-related quality-of-life score was 4.3 points better in the vibegron group (P < .0001). Measures of concern, coping, and sleep also improved significantly in the men taking vibegron and remained significant at 24 weeks (P < .0001).
Rates of adverse events were similar in the vibegron (45%) and placebo (39%) groups. The most common adverse event was hypertension, which occurred in 9% of the vibegron group and 8.3% of men in the placebo group.
The research was funded by Sumitomo Pharma America, Inc., which makes vibegron. Dr. Staskin is a consultant for Astellas, AzuraBio, Sumitomo Pharma America, Inc., and UroCure; is a lecturer for Astellas and Sumitomo; and holds other interests in UroCure, AzuraBio, and Quillitin Pharma. Three co-authors are Sumitomo employees; one is an investigator for Sumitomo, and another has consulted for Hologic, received research funding from Allergan/AbbVie and Uromedica, and been involved in clinical trials on behalf of Sumitomo. Dr. Watts reported no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
The medication vibegron led to improvements in symptoms of overactive bladder and overall quality of life in men undergoing treatment for benign prostatic hyperplasia, according to findings from a phase 3 trial presented at the annual meeting of the American Urological Association (AUA) and data published in the Journal of Urology.
“Vibegron was associated with significant reductions in daily micturition and urgency episodes, as well as our secondary endpoints,” David R. Staskin, MD, an associate professor of urology at Tufts University School of Medicine in Boston, told attendees. “Symptoms really did improve compared to placebo as early as week 2.”
Vibegron is a selective beta-3 adrenergic receptor agonist approved in 2020 by the US Food and Drug Administration for the treatment of overactive bladder.
However, treating overactive bladder symptoms in patients undergoing benign prostatic hyperplasia treatment is more complex because benign prostatic hyperplasia itself can contribute to overactive bladder symptoms, said Kara Watts, MD, an associate professor of urology at Montefiore Einstein in New York City, who was not involved in the new research.
“Management of overactive bladder in this setting may require treatment of benign prostatic hyperplasia as well, but a discussion of the relationship between benign prostatic hyperplasia and overactive bladder symptoms is important,” Dr. Watts told this news organization. “Beyond consideration of treatment for benign prostatic hyperplasia — which can be in the form of medications or surgeries to reduce the size of the prostate — treatment of overactive bladder can include behavioral modification,” such as avoiding bladder irritants, timed voiding, managing constipation, and nighttime liquid restriction,” as well as “medications, percutaneous tibial nerve stimulation, and occasionally more invasive options.”
Vibegron “represents a very attractive and effective pharmaceutical management option for overactive bladder,” both in patients with and without benign prostatic hyperplasia, Dr. Watts said. “It has a favorable side-effect profile compared to other oral agents that can be prescribed for overactive bladder, such as anticholinergics, and also has the added benefit of a much lower risk of urinary retention in comparison to most other oral agents.”
Among 1104 men at least 45 years old who were undergoing treatment for benign prostatic hyperplasia and had symptoms of overactive bladder, 538 received 75 mg of vibegron and 542 received a placebo. The men in the vibegron group showed 2.04 fewer mean daily urinations at 12 weeks and 2.2 fewer at 24 weeks compared to 1.3 fewer at both 12 and 24 weeks for men in the placebo group (P < .0001), according to the researchers.
The drug also reduced urgency of urination. Mean daily episodes of urgency were 2.88 fewer at 12 weeks and 3.07 fewer at 24 weeks in the vibegron group compared to 1.93 and 2.17 fewer, respectively, in the placebo group (P < .0001).
In secondary endpoints, those taking vibegron experienced 0.22 fewer episodes of nocturia (P = .002), 0.8 fewer episodes of urgency incontinence (P = .003), a 0.9-point difference in improvement in the International Prostate Symptom Score (P < .0001), and about 15 mL more volume voided (P < .0001) compared to those receiving placebo, the researchers reported.
“The clinical significance of these findings is that vibegron represents an effective pharmacologic option for managing overactive bladder in the context of concomitant benign prostatic hyperplasia, which is a broader context than its original approval for overactive bladder alone,” Dr. Watts said.
Data from 969 patients on the overactive bladder quality-of-life questionnaire found that the symptom bother score was 6.2 points better for men in the vibegron group than those who took a placebo (P < .0001) at 12 weeks. Similarly, the total health-related quality-of-life score was 4.3 points better in the vibegron group (P < .0001). Measures of concern, coping, and sleep also improved significantly in the men taking vibegron and remained significant at 24 weeks (P < .0001).
Rates of adverse events were similar in the vibegron (45%) and placebo (39%) groups. The most common adverse event was hypertension, which occurred in 9% of the vibegron group and 8.3% of men in the placebo group.
The research was funded by Sumitomo Pharma America, Inc., which makes vibegron. Dr. Staskin is a consultant for Astellas, AzuraBio, Sumitomo Pharma America, Inc., and UroCure; is a lecturer for Astellas and Sumitomo; and holds other interests in UroCure, AzuraBio, and Quillitin Pharma. Three co-authors are Sumitomo employees; one is an investigator for Sumitomo, and another has consulted for Hologic, received research funding from Allergan/AbbVie and Uromedica, and been involved in clinical trials on behalf of Sumitomo. Dr. Watts reported no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
The medication vibegron led to improvements in symptoms of overactive bladder and overall quality of life in men undergoing treatment for benign prostatic hyperplasia, according to findings from a phase 3 trial presented at the annual meeting of the American Urological Association (AUA) and data published in the Journal of Urology.
“Vibegron was associated with significant reductions in daily micturition and urgency episodes, as well as our secondary endpoints,” David R. Staskin, MD, an associate professor of urology at Tufts University School of Medicine in Boston, told attendees. “Symptoms really did improve compared to placebo as early as week 2.”
Vibegron is a selective beta-3 adrenergic receptor agonist approved in 2020 by the US Food and Drug Administration for the treatment of overactive bladder.
However, treating overactive bladder symptoms in patients undergoing benign prostatic hyperplasia treatment is more complex because benign prostatic hyperplasia itself can contribute to overactive bladder symptoms, said Kara Watts, MD, an associate professor of urology at Montefiore Einstein in New York City, who was not involved in the new research.
“Management of overactive bladder in this setting may require treatment of benign prostatic hyperplasia as well, but a discussion of the relationship between benign prostatic hyperplasia and overactive bladder symptoms is important,” Dr. Watts told this news organization. “Beyond consideration of treatment for benign prostatic hyperplasia — which can be in the form of medications or surgeries to reduce the size of the prostate — treatment of overactive bladder can include behavioral modification,” such as avoiding bladder irritants, timed voiding, managing constipation, and nighttime liquid restriction,” as well as “medications, percutaneous tibial nerve stimulation, and occasionally more invasive options.”
Vibegron “represents a very attractive and effective pharmaceutical management option for overactive bladder,” both in patients with and without benign prostatic hyperplasia, Dr. Watts said. “It has a favorable side-effect profile compared to other oral agents that can be prescribed for overactive bladder, such as anticholinergics, and also has the added benefit of a much lower risk of urinary retention in comparison to most other oral agents.”
Among 1104 men at least 45 years old who were undergoing treatment for benign prostatic hyperplasia and had symptoms of overactive bladder, 538 received 75 mg of vibegron and 542 received a placebo. The men in the vibegron group showed 2.04 fewer mean daily urinations at 12 weeks and 2.2 fewer at 24 weeks compared to 1.3 fewer at both 12 and 24 weeks for men in the placebo group (P < .0001), according to the researchers.
The drug also reduced urgency of urination. Mean daily episodes of urgency were 2.88 fewer at 12 weeks and 3.07 fewer at 24 weeks in the vibegron group compared to 1.93 and 2.17 fewer, respectively, in the placebo group (P < .0001).
In secondary endpoints, those taking vibegron experienced 0.22 fewer episodes of nocturia (P = .002), 0.8 fewer episodes of urgency incontinence (P = .003), a 0.9-point difference in improvement in the International Prostate Symptom Score (P < .0001), and about 15 mL more volume voided (P < .0001) compared to those receiving placebo, the researchers reported.
“The clinical significance of these findings is that vibegron represents an effective pharmacologic option for managing overactive bladder in the context of concomitant benign prostatic hyperplasia, which is a broader context than its original approval for overactive bladder alone,” Dr. Watts said.
Data from 969 patients on the overactive bladder quality-of-life questionnaire found that the symptom bother score was 6.2 points better for men in the vibegron group than those who took a placebo (P < .0001) at 12 weeks. Similarly, the total health-related quality-of-life score was 4.3 points better in the vibegron group (P < .0001). Measures of concern, coping, and sleep also improved significantly in the men taking vibegron and remained significant at 24 weeks (P < .0001).
Rates of adverse events were similar in the vibegron (45%) and placebo (39%) groups. The most common adverse event was hypertension, which occurred in 9% of the vibegron group and 8.3% of men in the placebo group.
The research was funded by Sumitomo Pharma America, Inc., which makes vibegron. Dr. Staskin is a consultant for Astellas, AzuraBio, Sumitomo Pharma America, Inc., and UroCure; is a lecturer for Astellas and Sumitomo; and holds other interests in UroCure, AzuraBio, and Quillitin Pharma. Three co-authors are Sumitomo employees; one is an investigator for Sumitomo, and another has consulted for Hologic, received research funding from Allergan/AbbVie and Uromedica, and been involved in clinical trials on behalf of Sumitomo. Dr. Watts reported no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM AUA 2024
Kids and Anti-Obesity Medications: Real-World Challenges
DENVER — The ability to provide adolescents with highly effective anti-obesity medications that now carry approvals from the US Food and Drug Administration (FDA) and support in guidelines offers reassurance of their use; however, a reality check often awaits for clinicians in terms of challenges ranging from accessing and affording the medications to managing real and rumored side effects.
Weighing in on the issues, experts at Obesity Medicine (OMA) 2024 offered some key strategies and practice hacks for overcoming those hurdles.
The incentive to provide treatment with popular glucagon-like peptide 1 (GLP-1) drugs such as semaglutide or the dual glucose-dependent insulinotropic peptide (GIP) GLP-1 tirzepatide lies in the evidence that their high efficacy in promoting weight loss, and hence preventing metabolic syndrome, has benefits that far outweigh the potential side effects, said Alaina Vidmar, MD, in presenting at the meeting.
“We can look at all the evidence and without question acknowledge that the GLP-1s/GIP agonists are the most effective agents that we currently have, with the least heterogeneity in response, and the most high responders compared with other agents,” said Dr. Vidmar, an assistant professor of clinical pediatrics at the Keck School of Medicine of University of Southern California and director of obesity medicine and bariatric surgery at Children’s Hospital Los Angeles.
The strength of the evidence is reflected in the landmark American Academy of Pediatrics (AAP) Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents With Obesity, which recommends that “pediatricians and other primary healthcare providers should offer adolescents 12 years and older with obesity weight loss pharmacotherapy, according to medication indications, risks and may offer adolescents 8 years old with obesity weight loss pharmacotherapy, according to medication indications, risks.”
The AAP guidance echoes the recommendations of the drug makers and FDA that “a combination of specific behavioral techniques within the context of family-based behavioral treatment and the use of pharmacotherapy may be necessary to prevent life-limiting complications over time.”
However, in real-world practice, with the various challenges in providing that intensive, comprehensive care, clinicians should be prepared to get creative: “We sometimes have to do the best we can with what we have because the watchful waiting approach is not effective and leads to more harm than good,” Dr. Vidmar said.
Facilitating Access
The ongoing reported shortages in the highly popular anti-obesity medications, as well as insurance denials and high costs, are among the leading obstacles, for adolescents and adults alike.
Dr. Vidmar noted that key strategies at her center, Children’s Hospital Los Angeles, have been essential, however, in helping at least facilitate the authorization process.
The center’s approach began with contacting all the payers the center has contracts with to determine which of their policies cover these medications for adults and pediatrics and which agents are covered.
“This took work on the front end, but it was worth it because it helped us understand the framework for what we were going to go up against every time that we prescribed these medications,” she said.
Furthermore, the center’s specialty pharmacy set up contracts to be able to provide the drugs within the institution.
While the strategy can’t entirely mitigate the ongoing distribution concerns, “our pharmacy is now able to share with our weight management program what GLP-1s are available so that we can be more efficient in our work,” Dr. Vidmar said.
The center also created a list of contacts to provide to patients and their families, detailing local pharmacies that were most likely to have the medications.
Another strategy Dr. Vidmar’s center has utilized to allow the timely implementation of a GLP-1 treatment plan while awaiting a drug to become available is to create an alternative protocol, for instance, using liraglutide when awaiting semaglutide.
“If we are unable to get the lower doses of a weekly agent for titration, we have a standard protocol to bridge instead with liraglutide, and our patients, pharmacies, and even our authorizations are aware of the protocol,” Dr. Vidmar said.
“We often do not have a lot of control or agency over the distribution concerns; however, we can be thoughtful within our programs about how we titrate patients up to their full doses,” Dr. Vidmar said.
Mitigating Side Effects
When the medications are available, the common gastrointestinal (GI) side effects of nausea, vomiting, and diarrhea of the once-weekly injections are well-known, and these side effects can affect quality of life and daily function, Dr. Vidmar noted.
“We have to acknowledge that the seminal trials of these agents showed that nausea and vomiting occur in more than half of young people who take these agents during the initial titration period, and while the side effects are tolerated by many, they can be disruptive to daily life,” she said.
Encouragingly, “we also do know that for the majority of patients, those effects improve over time, and for many, they can be mitigated with nutrition changes.”
Dr. Vidmar shared a handout her center issues with key recommendations for mitigating GI effects in youth. These include:
- Eat smaller meals and eat slower
- Eat about half of what you usually eat
- Take about 15-20 minutes to eat your meal
- Aim for 60 g of protein per day
- Add fruits, vegetables, whole grains, and lean proteins to meals
- Limit foods that are spicy, greasy, or fried
- Drink water instead of sweet drinks
Consider Zofran as needed during the titration period for GI symptoms. “We’ve started using this at our institution and are teaching patients how to use it; it can really help mitigate any ER visits when there is any vomiting by educating patients and families and providing appropriate expectations, and that has been very helpful,” Dr. Vidmar said.
Regarding the GI effects, Dr. Vidmar noted she has observed that tirzepatide use (though still off-label) in youths “tends to have milder GI side effects among younger people.”
Mood Concerns?
Another concern that has emerged in public discussion regarding side effects is that of possible mood and suicidal ideation, raising concerns for adults and adolescents alike.
Upon investigating the reports, the FDA, in a statement, offered cautious reassurance that their review, including reports and clinical trials, “did not find an association between use of GLP-1 RAs and the occurrence of suicidal thoughts or actions.”
Noting that the agency is continuing to look into the issue, however, the FDA recommends that “healthcare professionals should monitor for and advise patients using GLP-1 RAs to report new or worsening depression, suicidal thoughts, or any unusual changes in mood or behavior.”
Concurrent Psychiatric Pharmacotherapy
Meanwhile, with weight gain a known and often challenging side effect of various psychiatric drugs, particularly in younger patients, obesity treatment of adolescents may commonly involve patients who are also being treated with those therapies.
Key culprits include certain antidepressants and antipsychotic medications, such as tricyclic antidepressants, and second-generation antipsychotics, such as olanzapine.
In terms of the use of GLP-1 medications for those patients, research includes a recent study of semaglutide in patients who were also being treated with antidepressants.
The study, a post hoc analysis of the STEP trials, showed “clinically meaningful weight loss regardless of baseline antidepressant use, with an adverse event profile consistent with previous studies.”
First author Robert F. Kushner, MD, said the study offers “reassurance that individuals who are taking antidepressant medications have a similar weight loss response and side-effect profile compared to individuals who are not taking these medications.”
Dr. Kushner, a professor of medicine and medicine education at Northwestern University in Chicago, and his team have not evaluated the safety profile for concomitant use with antipsychotic drugs. However, he noted that “there are studies showing that the daily GLP-1 drug liraglutide has been shown to be useful in combating antipsychotic-induced weight gain.”
“Similar studies will need to be conducted for the more effective agents, semaglutide and tirzepatide,” he said.
To counter the weight gain effects of antispychotics, metformin has long been a standard recommendation, and Dr. Vidmar noted that “I have historically always used metformin in this setting and found it very effective.”
However, the newer anti-obesity medications could prove to be important in those cases, Dr. Vidmar added.
“I do think and predict that GLP-1 agonists will be as effective, if not more, in combating the weight gain-promoting effects of these agents and act as a nice adjuvant to this treatment paradigm for psychiatrists.”
Dr. Vidmar has participated in an advisory board for Rhythm Pharmaceuticals. Dr. Kushner is on the advisory boards for Novo Nordisk, Weight Watchers, Lilly, Boehringer Ingelheim, and Altimmune.
A version of this article appeared on Medscape.com.
DENVER — The ability to provide adolescents with highly effective anti-obesity medications that now carry approvals from the US Food and Drug Administration (FDA) and support in guidelines offers reassurance of their use; however, a reality check often awaits for clinicians in terms of challenges ranging from accessing and affording the medications to managing real and rumored side effects.
Weighing in on the issues, experts at Obesity Medicine (OMA) 2024 offered some key strategies and practice hacks for overcoming those hurdles.
The incentive to provide treatment with popular glucagon-like peptide 1 (GLP-1) drugs such as semaglutide or the dual glucose-dependent insulinotropic peptide (GIP) GLP-1 tirzepatide lies in the evidence that their high efficacy in promoting weight loss, and hence preventing metabolic syndrome, has benefits that far outweigh the potential side effects, said Alaina Vidmar, MD, in presenting at the meeting.
“We can look at all the evidence and without question acknowledge that the GLP-1s/GIP agonists are the most effective agents that we currently have, with the least heterogeneity in response, and the most high responders compared with other agents,” said Dr. Vidmar, an assistant professor of clinical pediatrics at the Keck School of Medicine of University of Southern California and director of obesity medicine and bariatric surgery at Children’s Hospital Los Angeles.
The strength of the evidence is reflected in the landmark American Academy of Pediatrics (AAP) Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents With Obesity, which recommends that “pediatricians and other primary healthcare providers should offer adolescents 12 years and older with obesity weight loss pharmacotherapy, according to medication indications, risks and may offer adolescents 8 years old with obesity weight loss pharmacotherapy, according to medication indications, risks.”
The AAP guidance echoes the recommendations of the drug makers and FDA that “a combination of specific behavioral techniques within the context of family-based behavioral treatment and the use of pharmacotherapy may be necessary to prevent life-limiting complications over time.”
However, in real-world practice, with the various challenges in providing that intensive, comprehensive care, clinicians should be prepared to get creative: “We sometimes have to do the best we can with what we have because the watchful waiting approach is not effective and leads to more harm than good,” Dr. Vidmar said.
Facilitating Access
The ongoing reported shortages in the highly popular anti-obesity medications, as well as insurance denials and high costs, are among the leading obstacles, for adolescents and adults alike.
Dr. Vidmar noted that key strategies at her center, Children’s Hospital Los Angeles, have been essential, however, in helping at least facilitate the authorization process.
The center’s approach began with contacting all the payers the center has contracts with to determine which of their policies cover these medications for adults and pediatrics and which agents are covered.
“This took work on the front end, but it was worth it because it helped us understand the framework for what we were going to go up against every time that we prescribed these medications,” she said.
Furthermore, the center’s specialty pharmacy set up contracts to be able to provide the drugs within the institution.
While the strategy can’t entirely mitigate the ongoing distribution concerns, “our pharmacy is now able to share with our weight management program what GLP-1s are available so that we can be more efficient in our work,” Dr. Vidmar said.
The center also created a list of contacts to provide to patients and their families, detailing local pharmacies that were most likely to have the medications.
Another strategy Dr. Vidmar’s center has utilized to allow the timely implementation of a GLP-1 treatment plan while awaiting a drug to become available is to create an alternative protocol, for instance, using liraglutide when awaiting semaglutide.
“If we are unable to get the lower doses of a weekly agent for titration, we have a standard protocol to bridge instead with liraglutide, and our patients, pharmacies, and even our authorizations are aware of the protocol,” Dr. Vidmar said.
“We often do not have a lot of control or agency over the distribution concerns; however, we can be thoughtful within our programs about how we titrate patients up to their full doses,” Dr. Vidmar said.
Mitigating Side Effects
When the medications are available, the common gastrointestinal (GI) side effects of nausea, vomiting, and diarrhea of the once-weekly injections are well-known, and these side effects can affect quality of life and daily function, Dr. Vidmar noted.
“We have to acknowledge that the seminal trials of these agents showed that nausea and vomiting occur in more than half of young people who take these agents during the initial titration period, and while the side effects are tolerated by many, they can be disruptive to daily life,” she said.
Encouragingly, “we also do know that for the majority of patients, those effects improve over time, and for many, they can be mitigated with nutrition changes.”
Dr. Vidmar shared a handout her center issues with key recommendations for mitigating GI effects in youth. These include:
- Eat smaller meals and eat slower
- Eat about half of what you usually eat
- Take about 15-20 minutes to eat your meal
- Aim for 60 g of protein per day
- Add fruits, vegetables, whole grains, and lean proteins to meals
- Limit foods that are spicy, greasy, or fried
- Drink water instead of sweet drinks
Consider Zofran as needed during the titration period for GI symptoms. “We’ve started using this at our institution and are teaching patients how to use it; it can really help mitigate any ER visits when there is any vomiting by educating patients and families and providing appropriate expectations, and that has been very helpful,” Dr. Vidmar said.
Regarding the GI effects, Dr. Vidmar noted she has observed that tirzepatide use (though still off-label) in youths “tends to have milder GI side effects among younger people.”
Mood Concerns?
Another concern that has emerged in public discussion regarding side effects is that of possible mood and suicidal ideation, raising concerns for adults and adolescents alike.
Upon investigating the reports, the FDA, in a statement, offered cautious reassurance that their review, including reports and clinical trials, “did not find an association between use of GLP-1 RAs and the occurrence of suicidal thoughts or actions.”
Noting that the agency is continuing to look into the issue, however, the FDA recommends that “healthcare professionals should monitor for and advise patients using GLP-1 RAs to report new or worsening depression, suicidal thoughts, or any unusual changes in mood or behavior.”
Concurrent Psychiatric Pharmacotherapy
Meanwhile, with weight gain a known and often challenging side effect of various psychiatric drugs, particularly in younger patients, obesity treatment of adolescents may commonly involve patients who are also being treated with those therapies.
Key culprits include certain antidepressants and antipsychotic medications, such as tricyclic antidepressants, and second-generation antipsychotics, such as olanzapine.
In terms of the use of GLP-1 medications for those patients, research includes a recent study of semaglutide in patients who were also being treated with antidepressants.
The study, a post hoc analysis of the STEP trials, showed “clinically meaningful weight loss regardless of baseline antidepressant use, with an adverse event profile consistent with previous studies.”
First author Robert F. Kushner, MD, said the study offers “reassurance that individuals who are taking antidepressant medications have a similar weight loss response and side-effect profile compared to individuals who are not taking these medications.”
Dr. Kushner, a professor of medicine and medicine education at Northwestern University in Chicago, and his team have not evaluated the safety profile for concomitant use with antipsychotic drugs. However, he noted that “there are studies showing that the daily GLP-1 drug liraglutide has been shown to be useful in combating antipsychotic-induced weight gain.”
“Similar studies will need to be conducted for the more effective agents, semaglutide and tirzepatide,” he said.
To counter the weight gain effects of antispychotics, metformin has long been a standard recommendation, and Dr. Vidmar noted that “I have historically always used metformin in this setting and found it very effective.”
However, the newer anti-obesity medications could prove to be important in those cases, Dr. Vidmar added.
“I do think and predict that GLP-1 agonists will be as effective, if not more, in combating the weight gain-promoting effects of these agents and act as a nice adjuvant to this treatment paradigm for psychiatrists.”
Dr. Vidmar has participated in an advisory board for Rhythm Pharmaceuticals. Dr. Kushner is on the advisory boards for Novo Nordisk, Weight Watchers, Lilly, Boehringer Ingelheim, and Altimmune.
A version of this article appeared on Medscape.com.
DENVER — The ability to provide adolescents with highly effective anti-obesity medications that now carry approvals from the US Food and Drug Administration (FDA) and support in guidelines offers reassurance of their use; however, a reality check often awaits for clinicians in terms of challenges ranging from accessing and affording the medications to managing real and rumored side effects.
Weighing in on the issues, experts at Obesity Medicine (OMA) 2024 offered some key strategies and practice hacks for overcoming those hurdles.
The incentive to provide treatment with popular glucagon-like peptide 1 (GLP-1) drugs such as semaglutide or the dual glucose-dependent insulinotropic peptide (GIP) GLP-1 tirzepatide lies in the evidence that their high efficacy in promoting weight loss, and hence preventing metabolic syndrome, has benefits that far outweigh the potential side effects, said Alaina Vidmar, MD, in presenting at the meeting.
“We can look at all the evidence and without question acknowledge that the GLP-1s/GIP agonists are the most effective agents that we currently have, with the least heterogeneity in response, and the most high responders compared with other agents,” said Dr. Vidmar, an assistant professor of clinical pediatrics at the Keck School of Medicine of University of Southern California and director of obesity medicine and bariatric surgery at Children’s Hospital Los Angeles.
The strength of the evidence is reflected in the landmark American Academy of Pediatrics (AAP) Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents With Obesity, which recommends that “pediatricians and other primary healthcare providers should offer adolescents 12 years and older with obesity weight loss pharmacotherapy, according to medication indications, risks and may offer adolescents 8 years old with obesity weight loss pharmacotherapy, according to medication indications, risks.”
The AAP guidance echoes the recommendations of the drug makers and FDA that “a combination of specific behavioral techniques within the context of family-based behavioral treatment and the use of pharmacotherapy may be necessary to prevent life-limiting complications over time.”
However, in real-world practice, with the various challenges in providing that intensive, comprehensive care, clinicians should be prepared to get creative: “We sometimes have to do the best we can with what we have because the watchful waiting approach is not effective and leads to more harm than good,” Dr. Vidmar said.
Facilitating Access
The ongoing reported shortages in the highly popular anti-obesity medications, as well as insurance denials and high costs, are among the leading obstacles, for adolescents and adults alike.
Dr. Vidmar noted that key strategies at her center, Children’s Hospital Los Angeles, have been essential, however, in helping at least facilitate the authorization process.
The center’s approach began with contacting all the payers the center has contracts with to determine which of their policies cover these medications for adults and pediatrics and which agents are covered.
“This took work on the front end, but it was worth it because it helped us understand the framework for what we were going to go up against every time that we prescribed these medications,” she said.
Furthermore, the center’s specialty pharmacy set up contracts to be able to provide the drugs within the institution.
While the strategy can’t entirely mitigate the ongoing distribution concerns, “our pharmacy is now able to share with our weight management program what GLP-1s are available so that we can be more efficient in our work,” Dr. Vidmar said.
The center also created a list of contacts to provide to patients and their families, detailing local pharmacies that were most likely to have the medications.
Another strategy Dr. Vidmar’s center has utilized to allow the timely implementation of a GLP-1 treatment plan while awaiting a drug to become available is to create an alternative protocol, for instance, using liraglutide when awaiting semaglutide.
“If we are unable to get the lower doses of a weekly agent for titration, we have a standard protocol to bridge instead with liraglutide, and our patients, pharmacies, and even our authorizations are aware of the protocol,” Dr. Vidmar said.
“We often do not have a lot of control or agency over the distribution concerns; however, we can be thoughtful within our programs about how we titrate patients up to their full doses,” Dr. Vidmar said.
Mitigating Side Effects
When the medications are available, the common gastrointestinal (GI) side effects of nausea, vomiting, and diarrhea of the once-weekly injections are well-known, and these side effects can affect quality of life and daily function, Dr. Vidmar noted.
“We have to acknowledge that the seminal trials of these agents showed that nausea and vomiting occur in more than half of young people who take these agents during the initial titration period, and while the side effects are tolerated by many, they can be disruptive to daily life,” she said.
Encouragingly, “we also do know that for the majority of patients, those effects improve over time, and for many, they can be mitigated with nutrition changes.”
Dr. Vidmar shared a handout her center issues with key recommendations for mitigating GI effects in youth. These include:
- Eat smaller meals and eat slower
- Eat about half of what you usually eat
- Take about 15-20 minutes to eat your meal
- Aim for 60 g of protein per day
- Add fruits, vegetables, whole grains, and lean proteins to meals
- Limit foods that are spicy, greasy, or fried
- Drink water instead of sweet drinks
Consider Zofran as needed during the titration period for GI symptoms. “We’ve started using this at our institution and are teaching patients how to use it; it can really help mitigate any ER visits when there is any vomiting by educating patients and families and providing appropriate expectations, and that has been very helpful,” Dr. Vidmar said.
Regarding the GI effects, Dr. Vidmar noted she has observed that tirzepatide use (though still off-label) in youths “tends to have milder GI side effects among younger people.”
Mood Concerns?
Another concern that has emerged in public discussion regarding side effects is that of possible mood and suicidal ideation, raising concerns for adults and adolescents alike.
Upon investigating the reports, the FDA, in a statement, offered cautious reassurance that their review, including reports and clinical trials, “did not find an association between use of GLP-1 RAs and the occurrence of suicidal thoughts or actions.”
Noting that the agency is continuing to look into the issue, however, the FDA recommends that “healthcare professionals should monitor for and advise patients using GLP-1 RAs to report new or worsening depression, suicidal thoughts, or any unusual changes in mood or behavior.”
Concurrent Psychiatric Pharmacotherapy
Meanwhile, with weight gain a known and often challenging side effect of various psychiatric drugs, particularly in younger patients, obesity treatment of adolescents may commonly involve patients who are also being treated with those therapies.
Key culprits include certain antidepressants and antipsychotic medications, such as tricyclic antidepressants, and second-generation antipsychotics, such as olanzapine.
In terms of the use of GLP-1 medications for those patients, research includes a recent study of semaglutide in patients who were also being treated with antidepressants.
The study, a post hoc analysis of the STEP trials, showed “clinically meaningful weight loss regardless of baseline antidepressant use, with an adverse event profile consistent with previous studies.”
First author Robert F. Kushner, MD, said the study offers “reassurance that individuals who are taking antidepressant medications have a similar weight loss response and side-effect profile compared to individuals who are not taking these medications.”
Dr. Kushner, a professor of medicine and medicine education at Northwestern University in Chicago, and his team have not evaluated the safety profile for concomitant use with antipsychotic drugs. However, he noted that “there are studies showing that the daily GLP-1 drug liraglutide has been shown to be useful in combating antipsychotic-induced weight gain.”
“Similar studies will need to be conducted for the more effective agents, semaglutide and tirzepatide,” he said.
To counter the weight gain effects of antispychotics, metformin has long been a standard recommendation, and Dr. Vidmar noted that “I have historically always used metformin in this setting and found it very effective.”
However, the newer anti-obesity medications could prove to be important in those cases, Dr. Vidmar added.
“I do think and predict that GLP-1 agonists will be as effective, if not more, in combating the weight gain-promoting effects of these agents and act as a nice adjuvant to this treatment paradigm for psychiatrists.”
Dr. Vidmar has participated in an advisory board for Rhythm Pharmaceuticals. Dr. Kushner is on the advisory boards for Novo Nordisk, Weight Watchers, Lilly, Boehringer Ingelheim, and Altimmune.
A version of this article appeared on Medscape.com.
FROM OBESITY MEDICINE 2024
Customized Video Games Promising for ADHD, Depression, in Children
, results of a new review and meta-analysis suggested.
Although the video game–based or “gamified” digital mental health interventions (DMHIs) were associated with modest improvements in ADHD symptoms and depression, investigators found no significant benefit in the treatment of anxiety.
“The studies are showing these video games really do work, at least for ADHD and depression but maybe not for anxiety,” said Barry Bryant, MD, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore.
“The results may assist clinicians as they make recommendations to patients and parents regarding the efficacy of using these video games to treat mental health conditions.”
The findings were presented at the American Psychiatric Association (APA) 2024 Annual Meeting.
A Major Problem
Childhood mental illness is a “big problem,” with about 20% of children facing some mental health challenge such as ADHD, anxiety, or depression, said Dr. Bryant. Unfortunately, these youngsters typically have to wait a while to see a provider, he added.
DMHIs may be an option to consider in the meantime to help meet the increasing demand for treatment, he said.
Gamified DMHIs are like other video games, in that players advance in levels on digital platforms and are rewarded for progress. But they’re created specifically to target certain mental health conditions.
An ADHD game, for example, might involve users completing activities that require an increasing degree of attention. Games focused on depression might incorporate mindfulness and meditation practices or cognitive behavioral elements.
Experts in child psychiatry are involved in developing such games along with professionals in business and video game technology, said Dr. Bryant.
But the question is: Do these games really work?
Effective for ADHD, Depression
Investigators reviewed nearly 30 randomized controlled trials of gamified DMHIs as a treatment for anxiety, depression, and/or ADHD in people younger than 18 years that were published from January 1, 1990, to April 7, 2023.
The trials tested a wide variety of gamified DMHIs that fit the inclusion criteria: A control condition, a digital game intervention, sufficient data to calculate effect size, and available in English.
A meta-analysis was performed to examine the therapeutic effects of the gamified DMHIs for ADHD, depression, and anxiety. For all studies, the active treatment was compared with the control condition using Hedges’ g to measure effect size and 95% CIs.
Dr. Bryant noted there was significant heterogeneity of therapeutic effects between the studies and their corresponding gamified interventions.
The study found gamified DMHIs had a modest therapeutic effect for treating ADHD (pooled g = 0.280; P = .005) and depression (pooled g = 0.279; P = .005) in children and adolescents.
But games targeting anxiety didn’t seem to have the same positive impact (pooled g = 0.074; P = .197).
The results suggest the games “show potential and promise” for certain mental health conditions and could offer a “bridge” to accessing more traditional therapies, Dr. Bryant said.
“Maybe this is something that can help these children until they can get to see a psychiatrist, or it could be part of a comprehensive treatment plan,” he said.
The goal is to “make something that kids want to play and engage with” especially if they’re reluctant to sit in a therapist’s office.
The results provide clinicians with information they can actually use in their practices, said Dr. Bryant, adding that his team hopes to get their study published.
Gaining Traction
Commenting on the research, James Sherer, MD, medical director, Addiction Psychiatry, Overlook Medical Center, Atlantic Health System, said the study shows the literature supports video games, and these games “are gaining traction” in the field.
He noted the app for one such game, EndeavorRx, was one of the first to be approved by the US Food and Drug Administration (FDA) to treat ADHD in young people aged 8-17 years.
EndeavorRx challenges players to chase mystic creatures, race through different worlds, and use “boosts” to problem-solve while building their own universe, according to the company website.
By being incentivized to engage in certain activities, “there’s a level of executive functioning that’s being exercised and the idea is to do that repetitively,” said Dr. Sherer.
Users and their parents report improved ADHD symptoms after playing the game. One of the studies included in the review found 73% of children who played EndeavorRx reported improvement in their attention.
The company says there have been no serious adverse events seen in any clinical trial of EndeavorRx.
Dr. Sherer noted that many child psychiatrists play some sort of video game with their young patients who may be on the autism spectrum or have a learning disability.
“That may be one of the few ways to communicate with and effectively bond with the patient,” he said.
Despite their reputation of being violent and associated with “toxic subcultures,” video games can do a lot of good and be “restorative” for patients of all ages, Dr. Sherer added.
No relevant conflicts of interest were disclosed.
A version of this article appeared on Medscape.com.
, results of a new review and meta-analysis suggested.
Although the video game–based or “gamified” digital mental health interventions (DMHIs) were associated with modest improvements in ADHD symptoms and depression, investigators found no significant benefit in the treatment of anxiety.
“The studies are showing these video games really do work, at least for ADHD and depression but maybe not for anxiety,” said Barry Bryant, MD, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore.
“The results may assist clinicians as they make recommendations to patients and parents regarding the efficacy of using these video games to treat mental health conditions.”
The findings were presented at the American Psychiatric Association (APA) 2024 Annual Meeting.
A Major Problem
Childhood mental illness is a “big problem,” with about 20% of children facing some mental health challenge such as ADHD, anxiety, or depression, said Dr. Bryant. Unfortunately, these youngsters typically have to wait a while to see a provider, he added.
DMHIs may be an option to consider in the meantime to help meet the increasing demand for treatment, he said.
Gamified DMHIs are like other video games, in that players advance in levels on digital platforms and are rewarded for progress. But they’re created specifically to target certain mental health conditions.
An ADHD game, for example, might involve users completing activities that require an increasing degree of attention. Games focused on depression might incorporate mindfulness and meditation practices or cognitive behavioral elements.
Experts in child psychiatry are involved in developing such games along with professionals in business and video game technology, said Dr. Bryant.
But the question is: Do these games really work?
Effective for ADHD, Depression
Investigators reviewed nearly 30 randomized controlled trials of gamified DMHIs as a treatment for anxiety, depression, and/or ADHD in people younger than 18 years that were published from January 1, 1990, to April 7, 2023.
The trials tested a wide variety of gamified DMHIs that fit the inclusion criteria: A control condition, a digital game intervention, sufficient data to calculate effect size, and available in English.
A meta-analysis was performed to examine the therapeutic effects of the gamified DMHIs for ADHD, depression, and anxiety. For all studies, the active treatment was compared with the control condition using Hedges’ g to measure effect size and 95% CIs.
Dr. Bryant noted there was significant heterogeneity of therapeutic effects between the studies and their corresponding gamified interventions.
The study found gamified DMHIs had a modest therapeutic effect for treating ADHD (pooled g = 0.280; P = .005) and depression (pooled g = 0.279; P = .005) in children and adolescents.
But games targeting anxiety didn’t seem to have the same positive impact (pooled g = 0.074; P = .197).
The results suggest the games “show potential and promise” for certain mental health conditions and could offer a “bridge” to accessing more traditional therapies, Dr. Bryant said.
“Maybe this is something that can help these children until they can get to see a psychiatrist, or it could be part of a comprehensive treatment plan,” he said.
The goal is to “make something that kids want to play and engage with” especially if they’re reluctant to sit in a therapist’s office.
The results provide clinicians with information they can actually use in their practices, said Dr. Bryant, adding that his team hopes to get their study published.
Gaining Traction
Commenting on the research, James Sherer, MD, medical director, Addiction Psychiatry, Overlook Medical Center, Atlantic Health System, said the study shows the literature supports video games, and these games “are gaining traction” in the field.
He noted the app for one such game, EndeavorRx, was one of the first to be approved by the US Food and Drug Administration (FDA) to treat ADHD in young people aged 8-17 years.
EndeavorRx challenges players to chase mystic creatures, race through different worlds, and use “boosts” to problem-solve while building their own universe, according to the company website.
By being incentivized to engage in certain activities, “there’s a level of executive functioning that’s being exercised and the idea is to do that repetitively,” said Dr. Sherer.
Users and their parents report improved ADHD symptoms after playing the game. One of the studies included in the review found 73% of children who played EndeavorRx reported improvement in their attention.
The company says there have been no serious adverse events seen in any clinical trial of EndeavorRx.
Dr. Sherer noted that many child psychiatrists play some sort of video game with their young patients who may be on the autism spectrum or have a learning disability.
“That may be one of the few ways to communicate with and effectively bond with the patient,” he said.
Despite their reputation of being violent and associated with “toxic subcultures,” video games can do a lot of good and be “restorative” for patients of all ages, Dr. Sherer added.
No relevant conflicts of interest were disclosed.
A version of this article appeared on Medscape.com.
, results of a new review and meta-analysis suggested.
Although the video game–based or “gamified” digital mental health interventions (DMHIs) were associated with modest improvements in ADHD symptoms and depression, investigators found no significant benefit in the treatment of anxiety.
“The studies are showing these video games really do work, at least for ADHD and depression but maybe not for anxiety,” said Barry Bryant, MD, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore.
“The results may assist clinicians as they make recommendations to patients and parents regarding the efficacy of using these video games to treat mental health conditions.”
The findings were presented at the American Psychiatric Association (APA) 2024 Annual Meeting.
A Major Problem
Childhood mental illness is a “big problem,” with about 20% of children facing some mental health challenge such as ADHD, anxiety, or depression, said Dr. Bryant. Unfortunately, these youngsters typically have to wait a while to see a provider, he added.
DMHIs may be an option to consider in the meantime to help meet the increasing demand for treatment, he said.
Gamified DMHIs are like other video games, in that players advance in levels on digital platforms and are rewarded for progress. But they’re created specifically to target certain mental health conditions.
An ADHD game, for example, might involve users completing activities that require an increasing degree of attention. Games focused on depression might incorporate mindfulness and meditation practices or cognitive behavioral elements.
Experts in child psychiatry are involved in developing such games along with professionals in business and video game technology, said Dr. Bryant.
But the question is: Do these games really work?
Effective for ADHD, Depression
Investigators reviewed nearly 30 randomized controlled trials of gamified DMHIs as a treatment for anxiety, depression, and/or ADHD in people younger than 18 years that were published from January 1, 1990, to April 7, 2023.
The trials tested a wide variety of gamified DMHIs that fit the inclusion criteria: A control condition, a digital game intervention, sufficient data to calculate effect size, and available in English.
A meta-analysis was performed to examine the therapeutic effects of the gamified DMHIs for ADHD, depression, and anxiety. For all studies, the active treatment was compared with the control condition using Hedges’ g to measure effect size and 95% CIs.
Dr. Bryant noted there was significant heterogeneity of therapeutic effects between the studies and their corresponding gamified interventions.
The study found gamified DMHIs had a modest therapeutic effect for treating ADHD (pooled g = 0.280; P = .005) and depression (pooled g = 0.279; P = .005) in children and adolescents.
But games targeting anxiety didn’t seem to have the same positive impact (pooled g = 0.074; P = .197).
The results suggest the games “show potential and promise” for certain mental health conditions and could offer a “bridge” to accessing more traditional therapies, Dr. Bryant said.
“Maybe this is something that can help these children until they can get to see a psychiatrist, or it could be part of a comprehensive treatment plan,” he said.
The goal is to “make something that kids want to play and engage with” especially if they’re reluctant to sit in a therapist’s office.
The results provide clinicians with information they can actually use in their practices, said Dr. Bryant, adding that his team hopes to get their study published.
Gaining Traction
Commenting on the research, James Sherer, MD, medical director, Addiction Psychiatry, Overlook Medical Center, Atlantic Health System, said the study shows the literature supports video games, and these games “are gaining traction” in the field.
He noted the app for one such game, EndeavorRx, was one of the first to be approved by the US Food and Drug Administration (FDA) to treat ADHD in young people aged 8-17 years.
EndeavorRx challenges players to chase mystic creatures, race through different worlds, and use “boosts” to problem-solve while building their own universe, according to the company website.
By being incentivized to engage in certain activities, “there’s a level of executive functioning that’s being exercised and the idea is to do that repetitively,” said Dr. Sherer.
Users and their parents report improved ADHD symptoms after playing the game. One of the studies included in the review found 73% of children who played EndeavorRx reported improvement in their attention.
The company says there have been no serious adverse events seen in any clinical trial of EndeavorRx.
Dr. Sherer noted that many child psychiatrists play some sort of video game with their young patients who may be on the autism spectrum or have a learning disability.
“That may be one of the few ways to communicate with and effectively bond with the patient,” he said.
Despite their reputation of being violent and associated with “toxic subcultures,” video games can do a lot of good and be “restorative” for patients of all ages, Dr. Sherer added.
No relevant conflicts of interest were disclosed.
A version of this article appeared on Medscape.com.
FROM APA 2024
New mRNA Vaccines in Development for Cancer and Infections
Martina Prelog, MD, a pediatric and adolescent medicine specialist at the University Hospital of Würzburg in Germany, reported on the principles, research status, and perspectives for these vaccines at the 25th Travel and Health Forum of the Center for Travel Medicine in Berlin.
To understand the future, the immunologist first examined the past. “The induction of cellular and humoral immune responses by externally injected mRNA was discovered in the 1990s,” she said.
Instability Challenge
Significant hurdles in mRNA vaccinations included the instability of mRNA and the immune system’s ability to identify foreign mRNA as a threat and destroy mRNA fragments. “The breakthrough toward vaccination came through Dr. Katalin Karikó, who, along with Dr. Drew Weissman, both of the University of Pennsylvania School of Medicine, discovered in 2005 that modifications of mRNA (replacing the nucleoside uridine with pseudouridine) enable better stability of mRNA, reduced immunogenicity, and higher translational capacity at the ribosomes,” said Dr. Prelog.
With this discovery, the two researchers paved the way for the development of mRNA vaccines against COVID-19 and other diseases. They were awarded the Nobel Prize in medicine for their discovery last year.
Improved Scalability
“Since 2009, mRNA vaccines have been studied as a treatment option for cancer,” said Dr. Prelog. “Since 2012, they have been studied for the influenza virus and respiratory syncytial virus [RSV].” Consequently, several mRNA vaccines are currently in development or in approval studies. “The mRNA technology offers the advantage of quickly and flexibly responding to new variants of pathogens and the ability to scale up production when there is high demand for a particular vaccine.”
Different forms and designations of mRNA vaccines are used, depending on the application and desired effect, said Dr. Prelog.
In nucleoside-modified mRNA vaccines, modifications in the mRNA sequence enable the mRNA to remain in the body longer and to induce protein synthesis more effectively.
Lipid nanoparticle (LNP)–encapsulated mRNA vaccines protect the coding mRNA sequences against degradation by the body’s enzymes and facilitate the uptake of mRNA into cells, where it then triggers the production of the desired protein. In addition, LNPs are involved in cell stimulation and support the self-adjuvant effect of mRNA vaccines, thus eliminating the need for adjuvants.
Self-amplifying mRNA vaccines include a special mRNA that replicates itself in the cell and contains a sequence for RNA replicase, in addition to the coding sequence for the protein. This composition enables increased production of the target protein without the need for a high amount of external mRNA administration. Such vaccines could trigger a longer and stronger immune response because the immune system has more time to interact with the protein.
Cancer Immunotherapy
Dr. Prelog also discussed personalized vaccines for cancer immunotherapy. Personalized mRNA vaccines are tailored to the patient’s genetic characteristics and antigens. They could be used in cancer immunotherapy to activate the immune system selectively against tumor cells.
Multivalent mRNA vaccines contain mRNA that codes for multiple antigens rather than just one protein to generate an immune response. These vaccines could be particularly useful in fighting pathogens with variable or changing surface structures or in eliciting protection against multiple pathogens simultaneously.
The technology of mRNA-encoded antibodies involves introducing mRNA into the cell, which creates light and heavy chains of antibodies. This step leads to the formation of antibodies targeted against toxins (eg, diphtheria and tetanus), animal venoms, infectious agents, or tumor cells.
Genetic Engineering
Dr. Prelog also reviewed genetic engineering techniques. In regenerative therapy or protein replacement therapy, skin fibroblasts or other cells are transfected with mRNA to enable conversion into induced pluripotent stem cells. This approach avoids the risk for DNA integration into the genome and associated mutation risks.
Another approach is making post-transcriptional modifications through RNA interference. For example, RNA structures can be used to inhibit the translation of disease-causing proteins. This technique is currently being tested against HIV and tumors such as melanoma.
In addition, mRNA technologies can be combined with CRISPR/Cas9 technology (“gene scissors”) to influence the creation of gene products even more precisely. The advantage of this technique is that mRNA is only transiently expressed, thus preventing unwanted side effects. Furthermore, mRNA is translated directly in the cytoplasm, leading to a faster initiation of gene editing.
Of the numerous ongoing clinical mRNA vaccine studies, around 70% focus on infections, about 12% on cancer, and the rest on autoimmune diseases and neurodegenerative disorders, said Dr. Prelog.
Research in Infections
Research in the fields of infectious diseases and oncology is the most advanced: mRNA vaccines against influenza and RSV are already in advanced clinical trials, Dr. Prelog told this news organization.
“Conventional influenza vaccines contain immunogenic surface molecules against hemagglutinin and neuraminidase in various combinations of influenza strains A and B and are produced in egg or cell cultures,” she said. “This is a time-consuming manufacturing process that takes months and, particularly with the egg-based process, bears the risk of changing the vaccine strain.”
“Additionally, influenza viruses undergo antigenic shift and drift through recombination, thus requiring annual adjustments to the vaccines. Thus, these influenza vaccines often lose accuracy in targeting circulating seasonal influenza strains.”
Several mRNA vaccines being tested contain not only coding sequences against hemagglutinin and neuraminidase but also for structural proteins of influenza viruses. “These are more conserved and mutate less easily, meaning they could serve as the basis for universal pandemic influenza vaccines,” said Dr. Prelog.
An advantage of mRNA vaccines, she added, is the strong cellular immune response that they elicit. This response is intended to provide additional protection alongside specific antibodies. An mRNA vaccine with coding sequences for the pre-fusion protein of RSV is in phase 3 trials for approval for vaccination in patients aged 60 years and older. It shows high effectiveness even in older patients and those with comorbidities.
Elaborate Purification Process
Bacterial origin plasmid DNA is used to produce mRNA vaccines. The mRNA vaccines for COVID-19 raised concerns that production-related DNA residues could pose a safety risk and cause autoimmune diseases.
These vaccines “typically undergo a very elaborate purification process,” said Dr. Prelog. “This involves enzymatic digestion with DNase to fragment and deplete plasmid DNA, followed by purification using chromatography columns, so that no safety-relevant DNA fragments should remain afterward.”
Thus, the Paul-Ehrlich-Institut also pointed out the very small, fragmented plasmid DNA residues of bacterial origin in mRNA COVID-19 vaccines pose no risk, unlike residual DNA from animal cell culture might pose in other vaccines.
Prevention and Therapy
In addition to the numerous advantages of mRNA vaccines (such as rapid adaptability to new or mutated pathogens, scalability, rapid production capability, self-adjuvant effect, strong induction of cellular immune responses, and safety), there are also challenges in RNA technology as a preventive and therapeutic measure, according to Dr. Prelog.
“Stability and storability, as well as the costs of new vaccine developments, play a role, as do the long-term effects regarding the persistence of antibody and cellular responses,” she said. The COVID-19 mRNA vaccines, for example, showed a well-maintained cellular immune response despite a tendency toward a rapid decline in humoral immune response.
“The experience with COVID-19 mRNA vaccines and the new vaccine developments based on mRNA technology give hope for an efficient and safe preventive and therapeutic use, particularly in the fields of infectious diseases and oncology,” Dr. Prelog concluded.
This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Martina Prelog, MD, a pediatric and adolescent medicine specialist at the University Hospital of Würzburg in Germany, reported on the principles, research status, and perspectives for these vaccines at the 25th Travel and Health Forum of the Center for Travel Medicine in Berlin.
To understand the future, the immunologist first examined the past. “The induction of cellular and humoral immune responses by externally injected mRNA was discovered in the 1990s,” she said.
Instability Challenge
Significant hurdles in mRNA vaccinations included the instability of mRNA and the immune system’s ability to identify foreign mRNA as a threat and destroy mRNA fragments. “The breakthrough toward vaccination came through Dr. Katalin Karikó, who, along with Dr. Drew Weissman, both of the University of Pennsylvania School of Medicine, discovered in 2005 that modifications of mRNA (replacing the nucleoside uridine with pseudouridine) enable better stability of mRNA, reduced immunogenicity, and higher translational capacity at the ribosomes,” said Dr. Prelog.
With this discovery, the two researchers paved the way for the development of mRNA vaccines against COVID-19 and other diseases. They were awarded the Nobel Prize in medicine for their discovery last year.
Improved Scalability
“Since 2009, mRNA vaccines have been studied as a treatment option for cancer,” said Dr. Prelog. “Since 2012, they have been studied for the influenza virus and respiratory syncytial virus [RSV].” Consequently, several mRNA vaccines are currently in development or in approval studies. “The mRNA technology offers the advantage of quickly and flexibly responding to new variants of pathogens and the ability to scale up production when there is high demand for a particular vaccine.”
Different forms and designations of mRNA vaccines are used, depending on the application and desired effect, said Dr. Prelog.
In nucleoside-modified mRNA vaccines, modifications in the mRNA sequence enable the mRNA to remain in the body longer and to induce protein synthesis more effectively.
Lipid nanoparticle (LNP)–encapsulated mRNA vaccines protect the coding mRNA sequences against degradation by the body’s enzymes and facilitate the uptake of mRNA into cells, where it then triggers the production of the desired protein. In addition, LNPs are involved in cell stimulation and support the self-adjuvant effect of mRNA vaccines, thus eliminating the need for adjuvants.
Self-amplifying mRNA vaccines include a special mRNA that replicates itself in the cell and contains a sequence for RNA replicase, in addition to the coding sequence for the protein. This composition enables increased production of the target protein without the need for a high amount of external mRNA administration. Such vaccines could trigger a longer and stronger immune response because the immune system has more time to interact with the protein.
Cancer Immunotherapy
Dr. Prelog also discussed personalized vaccines for cancer immunotherapy. Personalized mRNA vaccines are tailored to the patient’s genetic characteristics and antigens. They could be used in cancer immunotherapy to activate the immune system selectively against tumor cells.
Multivalent mRNA vaccines contain mRNA that codes for multiple antigens rather than just one protein to generate an immune response. These vaccines could be particularly useful in fighting pathogens with variable or changing surface structures or in eliciting protection against multiple pathogens simultaneously.
The technology of mRNA-encoded antibodies involves introducing mRNA into the cell, which creates light and heavy chains of antibodies. This step leads to the formation of antibodies targeted against toxins (eg, diphtheria and tetanus), animal venoms, infectious agents, or tumor cells.
Genetic Engineering
Dr. Prelog also reviewed genetic engineering techniques. In regenerative therapy or protein replacement therapy, skin fibroblasts or other cells are transfected with mRNA to enable conversion into induced pluripotent stem cells. This approach avoids the risk for DNA integration into the genome and associated mutation risks.
Another approach is making post-transcriptional modifications through RNA interference. For example, RNA structures can be used to inhibit the translation of disease-causing proteins. This technique is currently being tested against HIV and tumors such as melanoma.
In addition, mRNA technologies can be combined with CRISPR/Cas9 technology (“gene scissors”) to influence the creation of gene products even more precisely. The advantage of this technique is that mRNA is only transiently expressed, thus preventing unwanted side effects. Furthermore, mRNA is translated directly in the cytoplasm, leading to a faster initiation of gene editing.
Of the numerous ongoing clinical mRNA vaccine studies, around 70% focus on infections, about 12% on cancer, and the rest on autoimmune diseases and neurodegenerative disorders, said Dr. Prelog.
Research in Infections
Research in the fields of infectious diseases and oncology is the most advanced: mRNA vaccines against influenza and RSV are already in advanced clinical trials, Dr. Prelog told this news organization.
“Conventional influenza vaccines contain immunogenic surface molecules against hemagglutinin and neuraminidase in various combinations of influenza strains A and B and are produced in egg or cell cultures,” she said. “This is a time-consuming manufacturing process that takes months and, particularly with the egg-based process, bears the risk of changing the vaccine strain.”
“Additionally, influenza viruses undergo antigenic shift and drift through recombination, thus requiring annual adjustments to the vaccines. Thus, these influenza vaccines often lose accuracy in targeting circulating seasonal influenza strains.”
Several mRNA vaccines being tested contain not only coding sequences against hemagglutinin and neuraminidase but also for structural proteins of influenza viruses. “These are more conserved and mutate less easily, meaning they could serve as the basis for universal pandemic influenza vaccines,” said Dr. Prelog.
An advantage of mRNA vaccines, she added, is the strong cellular immune response that they elicit. This response is intended to provide additional protection alongside specific antibodies. An mRNA vaccine with coding sequences for the pre-fusion protein of RSV is in phase 3 trials for approval for vaccination in patients aged 60 years and older. It shows high effectiveness even in older patients and those with comorbidities.
Elaborate Purification Process
Bacterial origin plasmid DNA is used to produce mRNA vaccines. The mRNA vaccines for COVID-19 raised concerns that production-related DNA residues could pose a safety risk and cause autoimmune diseases.
These vaccines “typically undergo a very elaborate purification process,” said Dr. Prelog. “This involves enzymatic digestion with DNase to fragment and deplete plasmid DNA, followed by purification using chromatography columns, so that no safety-relevant DNA fragments should remain afterward.”
Thus, the Paul-Ehrlich-Institut also pointed out the very small, fragmented plasmid DNA residues of bacterial origin in mRNA COVID-19 vaccines pose no risk, unlike residual DNA from animal cell culture might pose in other vaccines.
Prevention and Therapy
In addition to the numerous advantages of mRNA vaccines (such as rapid adaptability to new or mutated pathogens, scalability, rapid production capability, self-adjuvant effect, strong induction of cellular immune responses, and safety), there are also challenges in RNA technology as a preventive and therapeutic measure, according to Dr. Prelog.
“Stability and storability, as well as the costs of new vaccine developments, play a role, as do the long-term effects regarding the persistence of antibody and cellular responses,” she said. The COVID-19 mRNA vaccines, for example, showed a well-maintained cellular immune response despite a tendency toward a rapid decline in humoral immune response.
“The experience with COVID-19 mRNA vaccines and the new vaccine developments based on mRNA technology give hope for an efficient and safe preventive and therapeutic use, particularly in the fields of infectious diseases and oncology,” Dr. Prelog concluded.
This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Martina Prelog, MD, a pediatric and adolescent medicine specialist at the University Hospital of Würzburg in Germany, reported on the principles, research status, and perspectives for these vaccines at the 25th Travel and Health Forum of the Center for Travel Medicine in Berlin.
To understand the future, the immunologist first examined the past. “The induction of cellular and humoral immune responses by externally injected mRNA was discovered in the 1990s,” she said.
Instability Challenge
Significant hurdles in mRNA vaccinations included the instability of mRNA and the immune system’s ability to identify foreign mRNA as a threat and destroy mRNA fragments. “The breakthrough toward vaccination came through Dr. Katalin Karikó, who, along with Dr. Drew Weissman, both of the University of Pennsylvania School of Medicine, discovered in 2005 that modifications of mRNA (replacing the nucleoside uridine with pseudouridine) enable better stability of mRNA, reduced immunogenicity, and higher translational capacity at the ribosomes,” said Dr. Prelog.
With this discovery, the two researchers paved the way for the development of mRNA vaccines against COVID-19 and other diseases. They were awarded the Nobel Prize in medicine for their discovery last year.
Improved Scalability
“Since 2009, mRNA vaccines have been studied as a treatment option for cancer,” said Dr. Prelog. “Since 2012, they have been studied for the influenza virus and respiratory syncytial virus [RSV].” Consequently, several mRNA vaccines are currently in development or in approval studies. “The mRNA technology offers the advantage of quickly and flexibly responding to new variants of pathogens and the ability to scale up production when there is high demand for a particular vaccine.”
Different forms and designations of mRNA vaccines are used, depending on the application and desired effect, said Dr. Prelog.
In nucleoside-modified mRNA vaccines, modifications in the mRNA sequence enable the mRNA to remain in the body longer and to induce protein synthesis more effectively.
Lipid nanoparticle (LNP)–encapsulated mRNA vaccines protect the coding mRNA sequences against degradation by the body’s enzymes and facilitate the uptake of mRNA into cells, where it then triggers the production of the desired protein. In addition, LNPs are involved in cell stimulation and support the self-adjuvant effect of mRNA vaccines, thus eliminating the need for adjuvants.
Self-amplifying mRNA vaccines include a special mRNA that replicates itself in the cell and contains a sequence for RNA replicase, in addition to the coding sequence for the protein. This composition enables increased production of the target protein without the need for a high amount of external mRNA administration. Such vaccines could trigger a longer and stronger immune response because the immune system has more time to interact with the protein.
Cancer Immunotherapy
Dr. Prelog also discussed personalized vaccines for cancer immunotherapy. Personalized mRNA vaccines are tailored to the patient’s genetic characteristics and antigens. They could be used in cancer immunotherapy to activate the immune system selectively against tumor cells.
Multivalent mRNA vaccines contain mRNA that codes for multiple antigens rather than just one protein to generate an immune response. These vaccines could be particularly useful in fighting pathogens with variable or changing surface structures or in eliciting protection against multiple pathogens simultaneously.
The technology of mRNA-encoded antibodies involves introducing mRNA into the cell, which creates light and heavy chains of antibodies. This step leads to the formation of antibodies targeted against toxins (eg, diphtheria and tetanus), animal venoms, infectious agents, or tumor cells.
Genetic Engineering
Dr. Prelog also reviewed genetic engineering techniques. In regenerative therapy or protein replacement therapy, skin fibroblasts or other cells are transfected with mRNA to enable conversion into induced pluripotent stem cells. This approach avoids the risk for DNA integration into the genome and associated mutation risks.
Another approach is making post-transcriptional modifications through RNA interference. For example, RNA structures can be used to inhibit the translation of disease-causing proteins. This technique is currently being tested against HIV and tumors such as melanoma.
In addition, mRNA technologies can be combined with CRISPR/Cas9 technology (“gene scissors”) to influence the creation of gene products even more precisely. The advantage of this technique is that mRNA is only transiently expressed, thus preventing unwanted side effects. Furthermore, mRNA is translated directly in the cytoplasm, leading to a faster initiation of gene editing.
Of the numerous ongoing clinical mRNA vaccine studies, around 70% focus on infections, about 12% on cancer, and the rest on autoimmune diseases and neurodegenerative disorders, said Dr. Prelog.
Research in Infections
Research in the fields of infectious diseases and oncology is the most advanced: mRNA vaccines against influenza and RSV are already in advanced clinical trials, Dr. Prelog told this news organization.
“Conventional influenza vaccines contain immunogenic surface molecules against hemagglutinin and neuraminidase in various combinations of influenza strains A and B and are produced in egg or cell cultures,” she said. “This is a time-consuming manufacturing process that takes months and, particularly with the egg-based process, bears the risk of changing the vaccine strain.”
“Additionally, influenza viruses undergo antigenic shift and drift through recombination, thus requiring annual adjustments to the vaccines. Thus, these influenza vaccines often lose accuracy in targeting circulating seasonal influenza strains.”
Several mRNA vaccines being tested contain not only coding sequences against hemagglutinin and neuraminidase but also for structural proteins of influenza viruses. “These are more conserved and mutate less easily, meaning they could serve as the basis for universal pandemic influenza vaccines,” said Dr. Prelog.
An advantage of mRNA vaccines, she added, is the strong cellular immune response that they elicit. This response is intended to provide additional protection alongside specific antibodies. An mRNA vaccine with coding sequences for the pre-fusion protein of RSV is in phase 3 trials for approval for vaccination in patients aged 60 years and older. It shows high effectiveness even in older patients and those with comorbidities.
Elaborate Purification Process
Bacterial origin plasmid DNA is used to produce mRNA vaccines. The mRNA vaccines for COVID-19 raised concerns that production-related DNA residues could pose a safety risk and cause autoimmune diseases.
These vaccines “typically undergo a very elaborate purification process,” said Dr. Prelog. “This involves enzymatic digestion with DNase to fragment and deplete plasmid DNA, followed by purification using chromatography columns, so that no safety-relevant DNA fragments should remain afterward.”
Thus, the Paul-Ehrlich-Institut also pointed out the very small, fragmented plasmid DNA residues of bacterial origin in mRNA COVID-19 vaccines pose no risk, unlike residual DNA from animal cell culture might pose in other vaccines.
Prevention and Therapy
In addition to the numerous advantages of mRNA vaccines (such as rapid adaptability to new or mutated pathogens, scalability, rapid production capability, self-adjuvant effect, strong induction of cellular immune responses, and safety), there are also challenges in RNA technology as a preventive and therapeutic measure, according to Dr. Prelog.
“Stability and storability, as well as the costs of new vaccine developments, play a role, as do the long-term effects regarding the persistence of antibody and cellular responses,” she said. The COVID-19 mRNA vaccines, for example, showed a well-maintained cellular immune response despite a tendency toward a rapid decline in humoral immune response.
“The experience with COVID-19 mRNA vaccines and the new vaccine developments based on mRNA technology give hope for an efficient and safe preventive and therapeutic use, particularly in the fields of infectious diseases and oncology,” Dr. Prelog concluded.
This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Rural Health System ‘Teetering on Brink’ of Collapse, Says AMA
Physicians are leaving healthcare in droves, “not because they don’t want to practice ... but because the system is making it more and more difficult for them to care for their patients,” Bruce Scott, MD, president-elect of the American Medical Association (AMA), said at a press conference May 9 at the National Rural Health Association’s Annual Conference in New Orleans.
He said that shrinking reimbursement rates and excessive administrative tasks are pushing doctors out of the workforce, exacerbating physician shortages in rural locations where 46 million Americans live.
A recent Centers for Disease Control and Prevention report found that people living in rural areas are more likely to die early from preventable causes than their urban counterparts, said Dr. Scott.
He said the AMA wants Congress to pass legislation to incentivize more physicians to work in rural areas and expand the number of rural and primary care residency spots. Historically, 80% of residents practice within 80 miles of where they complete residency, he said.
Dr. Scott also hopes Congress will revise the J-1 visa rules to allow qualified international medical graduates to continue to practice in the United States. He’d like to see the pandemic telehealth flexibilities made permanent because these loosened guidelines greatly improved care access for rural areas in recent years.
Lower Pay Affects Care in Rural, Urban Areas
Decreased reimbursements also have hit rural and urban doctors in independent practice particularly hard, Dr. Scott said. When adjusted for inflation, the current Medicare payment rate for physicians has dropped 29% since 2001, he said. Now that commercial payers tie their reimbursement models to the Medicare rate, physicians are experiencing “severe” financial stress amid rising practice costs and student loan debt.
He shared anecdotes about how these issues have affected his private otolaryngology practice in Louisville, Kentucky, a state where more than 2 million people live in federally designated primary care professional shortage areas.
“A major insurance company that controls over 60% of the private payer market in rural Kentucky [recently] offered us ... surgical rates less than they paid us 6 years ago,” he said.
Dr. Scott said physicians must make difficult choices. “Do we not invest in the latest physical equipment? Do we reduce our number of employees? Do we perhaps stop accepting new Medicare patients?”
He noted that physicians now spend twice as much time on prior authorizations and other administrative tasks as they do on direct patient care. According to a 2022 AMA survey, 33% of physicians reported that the cumbersome prior authorization process led to a serious adverse event for a patient. Eighty percent reported it caused their patient to forgo treatment altogether.
Dr. Scott, who will be sworn in as AMA president in June, said he experiences the frustration daily.
“I have to get on the phone and justify to an insurance person who rarely has gone to medical school, has never seen the patient, and heck, in my case, sometimes they can’t even say otolaryngology, much less tell me what the appropriate care is for my patient,” he said.
When asked about the impact of private equity in healthcare, Dr. Scott said there is room for all different modes of practice, but private equity could bring a unique benefit.
“They have deeper pockets to potentially invest in telehealth technology, AI, and better computer systems,” he said.
But, he said, some private equity-owned systems have abandoned rural areas, and in other regions they “push the physicians to move faster, see more patients, and do the things that are profit-driven.
“The key is to continue to provide ... quality medical care that is determined by an individual physician in consultation with the patient.”
A version of this article appeared on Medscape.com.
Physicians are leaving healthcare in droves, “not because they don’t want to practice ... but because the system is making it more and more difficult for them to care for their patients,” Bruce Scott, MD, president-elect of the American Medical Association (AMA), said at a press conference May 9 at the National Rural Health Association’s Annual Conference in New Orleans.
He said that shrinking reimbursement rates and excessive administrative tasks are pushing doctors out of the workforce, exacerbating physician shortages in rural locations where 46 million Americans live.
A recent Centers for Disease Control and Prevention report found that people living in rural areas are more likely to die early from preventable causes than their urban counterparts, said Dr. Scott.
He said the AMA wants Congress to pass legislation to incentivize more physicians to work in rural areas and expand the number of rural and primary care residency spots. Historically, 80% of residents practice within 80 miles of where they complete residency, he said.
Dr. Scott also hopes Congress will revise the J-1 visa rules to allow qualified international medical graduates to continue to practice in the United States. He’d like to see the pandemic telehealth flexibilities made permanent because these loosened guidelines greatly improved care access for rural areas in recent years.
Lower Pay Affects Care in Rural, Urban Areas
Decreased reimbursements also have hit rural and urban doctors in independent practice particularly hard, Dr. Scott said. When adjusted for inflation, the current Medicare payment rate for physicians has dropped 29% since 2001, he said. Now that commercial payers tie their reimbursement models to the Medicare rate, physicians are experiencing “severe” financial stress amid rising practice costs and student loan debt.
He shared anecdotes about how these issues have affected his private otolaryngology practice in Louisville, Kentucky, a state where more than 2 million people live in federally designated primary care professional shortage areas.
“A major insurance company that controls over 60% of the private payer market in rural Kentucky [recently] offered us ... surgical rates less than they paid us 6 years ago,” he said.
Dr. Scott said physicians must make difficult choices. “Do we not invest in the latest physical equipment? Do we reduce our number of employees? Do we perhaps stop accepting new Medicare patients?”
He noted that physicians now spend twice as much time on prior authorizations and other administrative tasks as they do on direct patient care. According to a 2022 AMA survey, 33% of physicians reported that the cumbersome prior authorization process led to a serious adverse event for a patient. Eighty percent reported it caused their patient to forgo treatment altogether.
Dr. Scott, who will be sworn in as AMA president in June, said he experiences the frustration daily.
“I have to get on the phone and justify to an insurance person who rarely has gone to medical school, has never seen the patient, and heck, in my case, sometimes they can’t even say otolaryngology, much less tell me what the appropriate care is for my patient,” he said.
When asked about the impact of private equity in healthcare, Dr. Scott said there is room for all different modes of practice, but private equity could bring a unique benefit.
“They have deeper pockets to potentially invest in telehealth technology, AI, and better computer systems,” he said.
But, he said, some private equity-owned systems have abandoned rural areas, and in other regions they “push the physicians to move faster, see more patients, and do the things that are profit-driven.
“The key is to continue to provide ... quality medical care that is determined by an individual physician in consultation with the patient.”
A version of this article appeared on Medscape.com.
Physicians are leaving healthcare in droves, “not because they don’t want to practice ... but because the system is making it more and more difficult for them to care for their patients,” Bruce Scott, MD, president-elect of the American Medical Association (AMA), said at a press conference May 9 at the National Rural Health Association’s Annual Conference in New Orleans.
He said that shrinking reimbursement rates and excessive administrative tasks are pushing doctors out of the workforce, exacerbating physician shortages in rural locations where 46 million Americans live.
A recent Centers for Disease Control and Prevention report found that people living in rural areas are more likely to die early from preventable causes than their urban counterparts, said Dr. Scott.
He said the AMA wants Congress to pass legislation to incentivize more physicians to work in rural areas and expand the number of rural and primary care residency spots. Historically, 80% of residents practice within 80 miles of where they complete residency, he said.
Dr. Scott also hopes Congress will revise the J-1 visa rules to allow qualified international medical graduates to continue to practice in the United States. He’d like to see the pandemic telehealth flexibilities made permanent because these loosened guidelines greatly improved care access for rural areas in recent years.
Lower Pay Affects Care in Rural, Urban Areas
Decreased reimbursements also have hit rural and urban doctors in independent practice particularly hard, Dr. Scott said. When adjusted for inflation, the current Medicare payment rate for physicians has dropped 29% since 2001, he said. Now that commercial payers tie their reimbursement models to the Medicare rate, physicians are experiencing “severe” financial stress amid rising practice costs and student loan debt.
He shared anecdotes about how these issues have affected his private otolaryngology practice in Louisville, Kentucky, a state where more than 2 million people live in federally designated primary care professional shortage areas.
“A major insurance company that controls over 60% of the private payer market in rural Kentucky [recently] offered us ... surgical rates less than they paid us 6 years ago,” he said.
Dr. Scott said physicians must make difficult choices. “Do we not invest in the latest physical equipment? Do we reduce our number of employees? Do we perhaps stop accepting new Medicare patients?”
He noted that physicians now spend twice as much time on prior authorizations and other administrative tasks as they do on direct patient care. According to a 2022 AMA survey, 33% of physicians reported that the cumbersome prior authorization process led to a serious adverse event for a patient. Eighty percent reported it caused their patient to forgo treatment altogether.
Dr. Scott, who will be sworn in as AMA president in June, said he experiences the frustration daily.
“I have to get on the phone and justify to an insurance person who rarely has gone to medical school, has never seen the patient, and heck, in my case, sometimes they can’t even say otolaryngology, much less tell me what the appropriate care is for my patient,” he said.
When asked about the impact of private equity in healthcare, Dr. Scott said there is room for all different modes of practice, but private equity could bring a unique benefit.
“They have deeper pockets to potentially invest in telehealth technology, AI, and better computer systems,” he said.
But, he said, some private equity-owned systems have abandoned rural areas, and in other regions they “push the physicians to move faster, see more patients, and do the things that are profit-driven.
“The key is to continue to provide ... quality medical care that is determined by an individual physician in consultation with the patient.”
A version of this article appeared on Medscape.com.