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COVID-19 vaccine mandates are working, public health experts say

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Thu, 11/11/2021 - 16:06

While COVID-19 vaccine mandates have sparked lawsuits and protests, the data shows that they’re working and increasing vaccination rates.

Some organizations have reported vaccination rates that jumped from less than 50% to more than 90%, according to ABC News. Workplace mandates have especially encouraged employees who were on the fence to get a shot.

“In general, vaccine mandates work,” James Colgrove, a public health professor at Columbia University’s Mailman School of Public Health, told ABC News.

For decades, the United States has monitored the effectiveness of vaccine mandates in schools, he noted, which have successfully required shots against measles, mumps, and other illnesses that used to be widespread. Certain employees, such as hospital workers, must take vaccines for their jobs, he said, and those requirements have also been effective over the years.

“The more normalized it becomes, the more people [know] someone else who is vaccinated, the more people will comply,” he said. “With any vaccine, the longer it’s been around, the more people get with it.”

With the widespread and contagious nature of COVID-19, workplaces have been forced to consider vaccine mandates to protect their employees and prevent worker shortages, Dr. Colgrove said.

Some companies began to issue vaccine rules this summer as the Delta variant caused a jump in cases, hospitalizations, and deaths. Major companies, including Google, Tyson Foods, United Airlines, and the Walt Disney Company, required in-person employees to get a shot. So far, the results from those mandates have been strong, ABC News reported.

For instance, Tyson announced a mandate in August, when less than half of its 140,000 employees were vaccinated. When the deadline came at the end of October, more than 60,000 additional employees had been vaccinated, and the vaccination rate was 96%.

“Has this made a difference in the health and safety of our team members? Absolutely. We’ve seen a significant decline in the number of active cases companywide,” Donnie King, CEO and president of Tyson Foods, said in a statement.

United Airlines has also shared that 99.7% of its 67,000 employees are vaccinated. Within 48 hours of announcing its mandate, the number of unvaccinated staffers fell from 593 to 320 people, ABC News reported.

Vaccine mandates appear to be working in the public sector as well. State health department officials in Washington told ABC News that the percentage of public employees who were vaccinated jumped from 49% in September to 96% by the vaccine mandate deadline in October.

Vaccination rates have also increased in New York City, where some employees in the fire, police, and sanitation departments protested the mandate. By the deadline, vaccination rates shifted from less than 75% to 82% in the fire department, 86% in the police department, and 91% of EMS personnel, ABC News reported.

Overall, vaccine mandates tend to reach groups who aren’t completely against the vaccine, medical experts told the news outlet. A small percentage of the population truly opposes the shot, and in most cases, unvaccinated people are on the fence or haven’t seen good enough messaging for it.

“When you look at vaccine resistance, the people who are the most opposed often make a very large amount of noise that is at odds with the actual numbers who are against vaccination,” Dr. Colgrove said.

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

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While COVID-19 vaccine mandates have sparked lawsuits and protests, the data shows that they’re working and increasing vaccination rates.

Some organizations have reported vaccination rates that jumped from less than 50% to more than 90%, according to ABC News. Workplace mandates have especially encouraged employees who were on the fence to get a shot.

“In general, vaccine mandates work,” James Colgrove, a public health professor at Columbia University’s Mailman School of Public Health, told ABC News.

For decades, the United States has monitored the effectiveness of vaccine mandates in schools, he noted, which have successfully required shots against measles, mumps, and other illnesses that used to be widespread. Certain employees, such as hospital workers, must take vaccines for their jobs, he said, and those requirements have also been effective over the years.

“The more normalized it becomes, the more people [know] someone else who is vaccinated, the more people will comply,” he said. “With any vaccine, the longer it’s been around, the more people get with it.”

With the widespread and contagious nature of COVID-19, workplaces have been forced to consider vaccine mandates to protect their employees and prevent worker shortages, Dr. Colgrove said.

Some companies began to issue vaccine rules this summer as the Delta variant caused a jump in cases, hospitalizations, and deaths. Major companies, including Google, Tyson Foods, United Airlines, and the Walt Disney Company, required in-person employees to get a shot. So far, the results from those mandates have been strong, ABC News reported.

For instance, Tyson announced a mandate in August, when less than half of its 140,000 employees were vaccinated. When the deadline came at the end of October, more than 60,000 additional employees had been vaccinated, and the vaccination rate was 96%.

“Has this made a difference in the health and safety of our team members? Absolutely. We’ve seen a significant decline in the number of active cases companywide,” Donnie King, CEO and president of Tyson Foods, said in a statement.

United Airlines has also shared that 99.7% of its 67,000 employees are vaccinated. Within 48 hours of announcing its mandate, the number of unvaccinated staffers fell from 593 to 320 people, ABC News reported.

Vaccine mandates appear to be working in the public sector as well. State health department officials in Washington told ABC News that the percentage of public employees who were vaccinated jumped from 49% in September to 96% by the vaccine mandate deadline in October.

Vaccination rates have also increased in New York City, where some employees in the fire, police, and sanitation departments protested the mandate. By the deadline, vaccination rates shifted from less than 75% to 82% in the fire department, 86% in the police department, and 91% of EMS personnel, ABC News reported.

Overall, vaccine mandates tend to reach groups who aren’t completely against the vaccine, medical experts told the news outlet. A small percentage of the population truly opposes the shot, and in most cases, unvaccinated people are on the fence or haven’t seen good enough messaging for it.

“When you look at vaccine resistance, the people who are the most opposed often make a very large amount of noise that is at odds with the actual numbers who are against vaccination,” Dr. Colgrove said.

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

While COVID-19 vaccine mandates have sparked lawsuits and protests, the data shows that they’re working and increasing vaccination rates.

Some organizations have reported vaccination rates that jumped from less than 50% to more than 90%, according to ABC News. Workplace mandates have especially encouraged employees who were on the fence to get a shot.

“In general, vaccine mandates work,” James Colgrove, a public health professor at Columbia University’s Mailman School of Public Health, told ABC News.

For decades, the United States has monitored the effectiveness of vaccine mandates in schools, he noted, which have successfully required shots against measles, mumps, and other illnesses that used to be widespread. Certain employees, such as hospital workers, must take vaccines for their jobs, he said, and those requirements have also been effective over the years.

“The more normalized it becomes, the more people [know] someone else who is vaccinated, the more people will comply,” he said. “With any vaccine, the longer it’s been around, the more people get with it.”

With the widespread and contagious nature of COVID-19, workplaces have been forced to consider vaccine mandates to protect their employees and prevent worker shortages, Dr. Colgrove said.

Some companies began to issue vaccine rules this summer as the Delta variant caused a jump in cases, hospitalizations, and deaths. Major companies, including Google, Tyson Foods, United Airlines, and the Walt Disney Company, required in-person employees to get a shot. So far, the results from those mandates have been strong, ABC News reported.

For instance, Tyson announced a mandate in August, when less than half of its 140,000 employees were vaccinated. When the deadline came at the end of October, more than 60,000 additional employees had been vaccinated, and the vaccination rate was 96%.

“Has this made a difference in the health and safety of our team members? Absolutely. We’ve seen a significant decline in the number of active cases companywide,” Donnie King, CEO and president of Tyson Foods, said in a statement.

United Airlines has also shared that 99.7% of its 67,000 employees are vaccinated. Within 48 hours of announcing its mandate, the number of unvaccinated staffers fell from 593 to 320 people, ABC News reported.

Vaccine mandates appear to be working in the public sector as well. State health department officials in Washington told ABC News that the percentage of public employees who were vaccinated jumped from 49% in September to 96% by the vaccine mandate deadline in October.

Vaccination rates have also increased in New York City, where some employees in the fire, police, and sanitation departments protested the mandate. By the deadline, vaccination rates shifted from less than 75% to 82% in the fire department, 86% in the police department, and 91% of EMS personnel, ABC News reported.

Overall, vaccine mandates tend to reach groups who aren’t completely against the vaccine, medical experts told the news outlet. A small percentage of the population truly opposes the shot, and in most cases, unvaccinated people are on the fence or haven’t seen good enough messaging for it.

“When you look at vaccine resistance, the people who are the most opposed often make a very large amount of noise that is at odds with the actual numbers who are against vaccination,” Dr. Colgrove said.

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

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Contact allergens in medical devices: A cause for concern?

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Tue, 05/03/2022 - 15:03

Despite the clinical value of medical devices, there is a potential for these products to cause adverse skin reactions in some patients. Findings from a European retrospective study, published in the European Journal of Allergy and Clinical Immunology, show that nearly one-quarter of patients with suspected allergic contact dermatitis were referred for patch testing for contact allergies associated with medical devices, highlighting the possibility of a high prevalence of contact allergens in these devices.

“We found it important to publish these findings, because up until now no clear figures have been reported regarding this particular clinical problem,” said study author Olivier Aerts, MD, a researcher in the contact allergy unit at the University Hospital Antwerp, Belgium, in an interview with this news organization.

For the study, Dr. Aerts and colleagues conducted a retrospective analysis of medical device users with suspected allergic contact dermatitis. All patients had been patch tested at a tertiary European clinic between 2018 and 2020.

The cohort included patients who experienced suspected contact allergy from medical adhesives (n = 57), gloves (n = 38), topical and surface medical devices (n = 38), glucose sensors and insulin pumps (n = 74), and prostheses (n = 75). Other medical products associated with contact allergy in another 44 patients included surgical glues, face masks, compression stockings, condoms, and suture materials.

Overall, 326 patients had been patch-tested during the 30-month study period. Approximately 25.8% of all patients – including 299 adults and 27 children – were referred for contact allergy associated with medical devices.

Acrylates were the most frequently encountered contact allergens and were found in diabetes devices and medical adhesives. Potential skin sensitizers included colophonium-related substances, D-limonene, isothiazolinone derivatives, salicylates, and sulphites, all of which were identified across most products.

According to the investigators, many of the labels for the medical devices made no mention of the potential skin sensitizers, except in the cases of some topical and surface disinfectants. And many topical products are often marketed as medical devices rather than cosmetics, further complicating labeling issues, according to Dr. Aerts.

“What should be done to help any patient suffering from allergic contact due to medical devices is that these devices should be labeled with all their components, or at the very least with the potential skin sensitizers these may contain,” Dr. Aerts explained. He added that manufacturers should “establish more cooperation with physicians/dermatologists who evaluate such patients,” a cooperation that often exists with cosmetic companies.

Dr. Aerts noted that while it’s important for patch testers and dermatologists to be aware of the prevalence of allergic contact dermatitis in medical device users, companies producing these devices should also be aware of these potential issues. “Additionally, legislators/regulators should perhaps focus some more on the cutaneous side effects these products may provoke,” he said, “as this awareness may hopefully also serve as a stimulant to perform more clinical allergy research in this field.”

Leonard Bielory, MD, an allergist at Robert Wood Johnson University Hospital in Rahway, New Jersey, told this news organization that the findings are “alarming” and should heighten clinicians’ awareness of the possibility of allergic contact dermatitis among medical device users.

Dr. Bielory, who wasn’t involved in the research, noted that the findings from this study may not be entirely generalizable to the U.S., given the study was performed in Europe. “In contrast to other countries, the U.S. is very conscientious about allergic responses to items being used in hospitals,” he added, “or such that the issue here is that many of these things would be an adverse reaction, which you have to report.” He suggested that further research in this field is needed to determine the prevalence of possible skin sensitizers in products specifically developed and marketed in the U.S.

The study had no specific funding. Dr. Aerts and Dr. Bielory have disclosed no relevant financial relationships.

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

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Despite the clinical value of medical devices, there is a potential for these products to cause adverse skin reactions in some patients. Findings from a European retrospective study, published in the European Journal of Allergy and Clinical Immunology, show that nearly one-quarter of patients with suspected allergic contact dermatitis were referred for patch testing for contact allergies associated with medical devices, highlighting the possibility of a high prevalence of contact allergens in these devices.

“We found it important to publish these findings, because up until now no clear figures have been reported regarding this particular clinical problem,” said study author Olivier Aerts, MD, a researcher in the contact allergy unit at the University Hospital Antwerp, Belgium, in an interview with this news organization.

For the study, Dr. Aerts and colleagues conducted a retrospective analysis of medical device users with suspected allergic contact dermatitis. All patients had been patch tested at a tertiary European clinic between 2018 and 2020.

The cohort included patients who experienced suspected contact allergy from medical adhesives (n = 57), gloves (n = 38), topical and surface medical devices (n = 38), glucose sensors and insulin pumps (n = 74), and prostheses (n = 75). Other medical products associated with contact allergy in another 44 patients included surgical glues, face masks, compression stockings, condoms, and suture materials.

Overall, 326 patients had been patch-tested during the 30-month study period. Approximately 25.8% of all patients – including 299 adults and 27 children – were referred for contact allergy associated with medical devices.

Acrylates were the most frequently encountered contact allergens and were found in diabetes devices and medical adhesives. Potential skin sensitizers included colophonium-related substances, D-limonene, isothiazolinone derivatives, salicylates, and sulphites, all of which were identified across most products.

According to the investigators, many of the labels for the medical devices made no mention of the potential skin sensitizers, except in the cases of some topical and surface disinfectants. And many topical products are often marketed as medical devices rather than cosmetics, further complicating labeling issues, according to Dr. Aerts.

“What should be done to help any patient suffering from allergic contact due to medical devices is that these devices should be labeled with all their components, or at the very least with the potential skin sensitizers these may contain,” Dr. Aerts explained. He added that manufacturers should “establish more cooperation with physicians/dermatologists who evaluate such patients,” a cooperation that often exists with cosmetic companies.

Dr. Aerts noted that while it’s important for patch testers and dermatologists to be aware of the prevalence of allergic contact dermatitis in medical device users, companies producing these devices should also be aware of these potential issues. “Additionally, legislators/regulators should perhaps focus some more on the cutaneous side effects these products may provoke,” he said, “as this awareness may hopefully also serve as a stimulant to perform more clinical allergy research in this field.”

Leonard Bielory, MD, an allergist at Robert Wood Johnson University Hospital in Rahway, New Jersey, told this news organization that the findings are “alarming” and should heighten clinicians’ awareness of the possibility of allergic contact dermatitis among medical device users.

Dr. Bielory, who wasn’t involved in the research, noted that the findings from this study may not be entirely generalizable to the U.S., given the study was performed in Europe. “In contrast to other countries, the U.S. is very conscientious about allergic responses to items being used in hospitals,” he added, “or such that the issue here is that many of these things would be an adverse reaction, which you have to report.” He suggested that further research in this field is needed to determine the prevalence of possible skin sensitizers in products specifically developed and marketed in the U.S.

The study had no specific funding. Dr. Aerts and Dr. Bielory have disclosed no relevant financial relationships.

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

Despite the clinical value of medical devices, there is a potential for these products to cause adverse skin reactions in some patients. Findings from a European retrospective study, published in the European Journal of Allergy and Clinical Immunology, show that nearly one-quarter of patients with suspected allergic contact dermatitis were referred for patch testing for contact allergies associated with medical devices, highlighting the possibility of a high prevalence of contact allergens in these devices.

“We found it important to publish these findings, because up until now no clear figures have been reported regarding this particular clinical problem,” said study author Olivier Aerts, MD, a researcher in the contact allergy unit at the University Hospital Antwerp, Belgium, in an interview with this news organization.

For the study, Dr. Aerts and colleagues conducted a retrospective analysis of medical device users with suspected allergic contact dermatitis. All patients had been patch tested at a tertiary European clinic between 2018 and 2020.

The cohort included patients who experienced suspected contact allergy from medical adhesives (n = 57), gloves (n = 38), topical and surface medical devices (n = 38), glucose sensors and insulin pumps (n = 74), and prostheses (n = 75). Other medical products associated with contact allergy in another 44 patients included surgical glues, face masks, compression stockings, condoms, and suture materials.

Overall, 326 patients had been patch-tested during the 30-month study period. Approximately 25.8% of all patients – including 299 adults and 27 children – were referred for contact allergy associated with medical devices.

Acrylates were the most frequently encountered contact allergens and were found in diabetes devices and medical adhesives. Potential skin sensitizers included colophonium-related substances, D-limonene, isothiazolinone derivatives, salicylates, and sulphites, all of which were identified across most products.

According to the investigators, many of the labels for the medical devices made no mention of the potential skin sensitizers, except in the cases of some topical and surface disinfectants. And many topical products are often marketed as medical devices rather than cosmetics, further complicating labeling issues, according to Dr. Aerts.

“What should be done to help any patient suffering from allergic contact due to medical devices is that these devices should be labeled with all their components, or at the very least with the potential skin sensitizers these may contain,” Dr. Aerts explained. He added that manufacturers should “establish more cooperation with physicians/dermatologists who evaluate such patients,” a cooperation that often exists with cosmetic companies.

Dr. Aerts noted that while it’s important for patch testers and dermatologists to be aware of the prevalence of allergic contact dermatitis in medical device users, companies producing these devices should also be aware of these potential issues. “Additionally, legislators/regulators should perhaps focus some more on the cutaneous side effects these products may provoke,” he said, “as this awareness may hopefully also serve as a stimulant to perform more clinical allergy research in this field.”

Leonard Bielory, MD, an allergist at Robert Wood Johnson University Hospital in Rahway, New Jersey, told this news organization that the findings are “alarming” and should heighten clinicians’ awareness of the possibility of allergic contact dermatitis among medical device users.

Dr. Bielory, who wasn’t involved in the research, noted that the findings from this study may not be entirely generalizable to the U.S., given the study was performed in Europe. “In contrast to other countries, the U.S. is very conscientious about allergic responses to items being used in hospitals,” he added, “or such that the issue here is that many of these things would be an adverse reaction, which you have to report.” He suggested that further research in this field is needed to determine the prevalence of possible skin sensitizers in products specifically developed and marketed in the U.S.

The study had no specific funding. Dr. Aerts and Dr. Bielory have disclosed no relevant financial relationships.

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

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Cannabinoids being studied for a variety of dermatologic conditions

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Fri, 11/12/2021 - 10:47

Clinicians who are stumped on how to counsel patients asking about whether cannabinoids benefit various skin-related ailments are not alone.

Dr. Todd S. Anhalt

“When you walk into places like CVS or Walgreens, you see lots of displays for CBD creams and oils,” Todd S. Anhalt, MD, said during the annual meeting of the Pacific Dermatologic Association. “The problem is, we don’t know what’s in them or who made them or how good they are. That’s going to be a problem for a while.”

According to Dr. Anhalt, clinical professor emeritus of dermatology at Stanford (Calif.) University, there are about 140 active cannabinoid compounds in cannabis, but the most important ones are THC and cannabidiol (CBD). There are three types of cannabinoids, based on where the cannabidiol is produced: endocannabinoids, which are produced in the human body; phytocannabinoids, which are derived from plants such as marijuana and hemp; and synthetic cannabinoids, which are derived in labs.

Dr. Anhalt described the endocannabinoid system as a conserved network of molecular signaling made of several components: signaling molecules (endocannabinoids), endocannabinoid receptors (CB-1 and CB-2), enzymes, and transporters. There is also overlap between cannabinoids and terpenes, which are responsible for flavor and aroma in plants and marijuana and can enhance the effects of CBD.

“For the most part, CB-1 receptors are in the central nervous system and CB-2 [receptors] are mostly in the periphery,” including the skin and digestive system, said Dr. Anhalt, who practices at the California Skin Institute in Los Altos, Calif. “This is interesting because one of the main conditions I recommend cannabidiol for is in patients with peripheral neuropathy, despite the fact they may be on all sorts of medications such as Neurontin and Lyrica or tricyclic antidepressants. Sometimes they don’t get much relief from those. I have had many patients tell me that they have had reduction of pain and increased functionality using the CBD creams.” CB-2 receptors, he noted, are located in keratinocytes, sensory receptors, sweat glands, fibroblasts, Langerhans cells, melanocytes, and sebaceous glands.

Recent research shows that the endocannabinoid system is involved in modulation of the CNS and in immune function, particularly skin homeostasis and barrier function. “We know that barrier function can be affected by the generation of oxidative species,” he said. “The stress that it causes can decrease barrier function and lead to cytokine release and itch. CBDs have been shown to enter cells, target and upregulate genes with decreased oxidation and inflammation, and protect membrane integrity in skin cells. Therefore, this might be helpful in atopic dermatitis.” Other potential uses in dermatology include wound healing, acne, hair growth modulation, skin and hair pigmentation, skin infections, psoriasis, and cutaneous malignancies, as well as neuropathic pain.



Evidence is strongest for neuropathic pain, he said, which is mediated by CB-1 receptors peripherally, followed by itch and atopic dermatitis. The authors of a 2017 systematic review concluded that “low-strength” evidence exists to suggest that cannabis alleviates neuropathic pain, with insufficient evidence for other types of pain.

Topical CBD comes in various forms: oils (usually hemp oil), creams, and lotions, Dr. Anhalt said. “I advise patients to apply it 2-4 times per day depending on how anxious or uncomfortable they are. It takes my patients 10 days to 2 weeks before they notice anything at all.”

For atopic dermatitis, it could be useful “not to use it instead of a moisturizer, but as a moisturizer,” Dr. Anhalt advised. “You can have a patient get big jars of CBD creams and lotions. They may have to try a few before they find one that they really like, but you can replace all of the other moisturizers that you’re using right now in patients who have a lot of itch.”

As for CBD’s effect on peripheral neuropathy, the medical literature is lacking, but some studies show low to moderate evidence of efficacy. For example, a Cochrane Review found that a 30% or greater pain reduction was achieved by 39% of patients who used cannabis-based treatments, vs. 33% of those on placebo.

“I would not suggest CBD as a first-line drug unless it’s very mild peripheral neuropathy, but for patients who are on gabapentin who are better but not better enough, this is an excellent adjunct,” Dr. Anhalt said. “It’s worth trying. It’s not too expensive and it’s really safe.”

The application of topical CBD to treat cutaneous malignancies has not yet shown evidence of significant efficacy, while using CBDs for acne holds promise. “The endogenous cannabinoid system is involved in the production of lipids,” he said. “Cannabinoids have an antilipogenic activity, so they decrease sebum production. CBD could help patients with mild acne who are reluctant to use other types of medications. For this and other potential dermatologic applications, lots more studies need to be done.”

Dr. Anhalt reported having no financial disclosures.

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Clinicians who are stumped on how to counsel patients asking about whether cannabinoids benefit various skin-related ailments are not alone.

Dr. Todd S. Anhalt

“When you walk into places like CVS or Walgreens, you see lots of displays for CBD creams and oils,” Todd S. Anhalt, MD, said during the annual meeting of the Pacific Dermatologic Association. “The problem is, we don’t know what’s in them or who made them or how good they are. That’s going to be a problem for a while.”

According to Dr. Anhalt, clinical professor emeritus of dermatology at Stanford (Calif.) University, there are about 140 active cannabinoid compounds in cannabis, but the most important ones are THC and cannabidiol (CBD). There are three types of cannabinoids, based on where the cannabidiol is produced: endocannabinoids, which are produced in the human body; phytocannabinoids, which are derived from plants such as marijuana and hemp; and synthetic cannabinoids, which are derived in labs.

Dr. Anhalt described the endocannabinoid system as a conserved network of molecular signaling made of several components: signaling molecules (endocannabinoids), endocannabinoid receptors (CB-1 and CB-2), enzymes, and transporters. There is also overlap between cannabinoids and terpenes, which are responsible for flavor and aroma in plants and marijuana and can enhance the effects of CBD.

“For the most part, CB-1 receptors are in the central nervous system and CB-2 [receptors] are mostly in the periphery,” including the skin and digestive system, said Dr. Anhalt, who practices at the California Skin Institute in Los Altos, Calif. “This is interesting because one of the main conditions I recommend cannabidiol for is in patients with peripheral neuropathy, despite the fact they may be on all sorts of medications such as Neurontin and Lyrica or tricyclic antidepressants. Sometimes they don’t get much relief from those. I have had many patients tell me that they have had reduction of pain and increased functionality using the CBD creams.” CB-2 receptors, he noted, are located in keratinocytes, sensory receptors, sweat glands, fibroblasts, Langerhans cells, melanocytes, and sebaceous glands.

Recent research shows that the endocannabinoid system is involved in modulation of the CNS and in immune function, particularly skin homeostasis and barrier function. “We know that barrier function can be affected by the generation of oxidative species,” he said. “The stress that it causes can decrease barrier function and lead to cytokine release and itch. CBDs have been shown to enter cells, target and upregulate genes with decreased oxidation and inflammation, and protect membrane integrity in skin cells. Therefore, this might be helpful in atopic dermatitis.” Other potential uses in dermatology include wound healing, acne, hair growth modulation, skin and hair pigmentation, skin infections, psoriasis, and cutaneous malignancies, as well as neuropathic pain.



Evidence is strongest for neuropathic pain, he said, which is mediated by CB-1 receptors peripherally, followed by itch and atopic dermatitis. The authors of a 2017 systematic review concluded that “low-strength” evidence exists to suggest that cannabis alleviates neuropathic pain, with insufficient evidence for other types of pain.

Topical CBD comes in various forms: oils (usually hemp oil), creams, and lotions, Dr. Anhalt said. “I advise patients to apply it 2-4 times per day depending on how anxious or uncomfortable they are. It takes my patients 10 days to 2 weeks before they notice anything at all.”

For atopic dermatitis, it could be useful “not to use it instead of a moisturizer, but as a moisturizer,” Dr. Anhalt advised. “You can have a patient get big jars of CBD creams and lotions. They may have to try a few before they find one that they really like, but you can replace all of the other moisturizers that you’re using right now in patients who have a lot of itch.”

As for CBD’s effect on peripheral neuropathy, the medical literature is lacking, but some studies show low to moderate evidence of efficacy. For example, a Cochrane Review found that a 30% or greater pain reduction was achieved by 39% of patients who used cannabis-based treatments, vs. 33% of those on placebo.

“I would not suggest CBD as a first-line drug unless it’s very mild peripheral neuropathy, but for patients who are on gabapentin who are better but not better enough, this is an excellent adjunct,” Dr. Anhalt said. “It’s worth trying. It’s not too expensive and it’s really safe.”

The application of topical CBD to treat cutaneous malignancies has not yet shown evidence of significant efficacy, while using CBDs for acne holds promise. “The endogenous cannabinoid system is involved in the production of lipids,” he said. “Cannabinoids have an antilipogenic activity, so they decrease sebum production. CBD could help patients with mild acne who are reluctant to use other types of medications. For this and other potential dermatologic applications, lots more studies need to be done.”

Dr. Anhalt reported having no financial disclosures.

Clinicians who are stumped on how to counsel patients asking about whether cannabinoids benefit various skin-related ailments are not alone.

Dr. Todd S. Anhalt

“When you walk into places like CVS or Walgreens, you see lots of displays for CBD creams and oils,” Todd S. Anhalt, MD, said during the annual meeting of the Pacific Dermatologic Association. “The problem is, we don’t know what’s in them or who made them or how good they are. That’s going to be a problem for a while.”

According to Dr. Anhalt, clinical professor emeritus of dermatology at Stanford (Calif.) University, there are about 140 active cannabinoid compounds in cannabis, but the most important ones are THC and cannabidiol (CBD). There are three types of cannabinoids, based on where the cannabidiol is produced: endocannabinoids, which are produced in the human body; phytocannabinoids, which are derived from plants such as marijuana and hemp; and synthetic cannabinoids, which are derived in labs.

Dr. Anhalt described the endocannabinoid system as a conserved network of molecular signaling made of several components: signaling molecules (endocannabinoids), endocannabinoid receptors (CB-1 and CB-2), enzymes, and transporters. There is also overlap between cannabinoids and terpenes, which are responsible for flavor and aroma in plants and marijuana and can enhance the effects of CBD.

“For the most part, CB-1 receptors are in the central nervous system and CB-2 [receptors] are mostly in the periphery,” including the skin and digestive system, said Dr. Anhalt, who practices at the California Skin Institute in Los Altos, Calif. “This is interesting because one of the main conditions I recommend cannabidiol for is in patients with peripheral neuropathy, despite the fact they may be on all sorts of medications such as Neurontin and Lyrica or tricyclic antidepressants. Sometimes they don’t get much relief from those. I have had many patients tell me that they have had reduction of pain and increased functionality using the CBD creams.” CB-2 receptors, he noted, are located in keratinocytes, sensory receptors, sweat glands, fibroblasts, Langerhans cells, melanocytes, and sebaceous glands.

Recent research shows that the endocannabinoid system is involved in modulation of the CNS and in immune function, particularly skin homeostasis and barrier function. “We know that barrier function can be affected by the generation of oxidative species,” he said. “The stress that it causes can decrease barrier function and lead to cytokine release and itch. CBDs have been shown to enter cells, target and upregulate genes with decreased oxidation and inflammation, and protect membrane integrity in skin cells. Therefore, this might be helpful in atopic dermatitis.” Other potential uses in dermatology include wound healing, acne, hair growth modulation, skin and hair pigmentation, skin infections, psoriasis, and cutaneous malignancies, as well as neuropathic pain.



Evidence is strongest for neuropathic pain, he said, which is mediated by CB-1 receptors peripherally, followed by itch and atopic dermatitis. The authors of a 2017 systematic review concluded that “low-strength” evidence exists to suggest that cannabis alleviates neuropathic pain, with insufficient evidence for other types of pain.

Topical CBD comes in various forms: oils (usually hemp oil), creams, and lotions, Dr. Anhalt said. “I advise patients to apply it 2-4 times per day depending on how anxious or uncomfortable they are. It takes my patients 10 days to 2 weeks before they notice anything at all.”

For atopic dermatitis, it could be useful “not to use it instead of a moisturizer, but as a moisturizer,” Dr. Anhalt advised. “You can have a patient get big jars of CBD creams and lotions. They may have to try a few before they find one that they really like, but you can replace all of the other moisturizers that you’re using right now in patients who have a lot of itch.”

As for CBD’s effect on peripheral neuropathy, the medical literature is lacking, but some studies show low to moderate evidence of efficacy. For example, a Cochrane Review found that a 30% or greater pain reduction was achieved by 39% of patients who used cannabis-based treatments, vs. 33% of those on placebo.

“I would not suggest CBD as a first-line drug unless it’s very mild peripheral neuropathy, but for patients who are on gabapentin who are better but not better enough, this is an excellent adjunct,” Dr. Anhalt said. “It’s worth trying. It’s not too expensive and it’s really safe.”

The application of topical CBD to treat cutaneous malignancies has not yet shown evidence of significant efficacy, while using CBDs for acne holds promise. “The endogenous cannabinoid system is involved in the production of lipids,” he said. “Cannabinoids have an antilipogenic activity, so they decrease sebum production. CBD could help patients with mild acne who are reluctant to use other types of medications. For this and other potential dermatologic applications, lots more studies need to be done.”

Dr. Anhalt reported having no financial disclosures.

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Step right up, folks, for a public dissection

Article Type
Changed
Tue, 02/14/2023 - 12:59

 

The greatest autopsy on Earth?

The LOTME staff would like to apologize in advance. The following item contains historical facts.

P.T. Barnum is a rather controversial figure in American history. The greatest show on Earth was certainly popular in its day. However, Barnum got his start in 1835 by leasing a slave named Joyce Heth, an elderly Black woman who told vivid stories of caring for a young George Washington. He toured her around the country, advertising her as a 160-year-old woman who served as George Washington’s nanny. When Ms. Heth died the next year, Barnum sold tickets to the autopsy, charging the equivalent of $30 in today’s money.

fstop123/E+

When a doctor announced that Ms. Heth was actually 75-80 when she died, it caused great controversy in the press and ruined Barnum’s career. Wait, no, that’s not right. The opposite, actually. He weathered the storm, built his famous circus, and never again committed a hoax.

It’s difficult to quantify how wrong publicly dissecting a person and charging people to see said dissection is, but that was almost 200 years ago. At the very least, we can say that such terrible behavior is firmly in the distant past.

Oh wait.

David Saunders, a 98-year-old veteran of World War II and the Korean War, donated his body to science. His body, however, was purchased by DeathScience.org from a medical lab – with the buyer supposedly misleading the medical lab about its intentions, which was for use at the traveling Oddities and Curiosities Expo. Tickets went for up to $500 each to witness the public autopsy of Mr. Saunders’ body, which took place at a Marriott in Portland, Ore. It promised to be an exciting, all-day event from 9 a.m. to 4 p.m., with a break for lunch, of course. You can’t have an autopsy without a catered lunch.

Another public autopsy event was scheduled in Seattle but canceled after news of the first event broke. Oh, and for that extra little kick, Mr. Saunders died from COVID-19, meaning that all those paying customers were exposed.

P.T. Barnum is probably rolling over in his grave right now. His autopsy tickets were a bargain.
 

Go ahead, have that soda before math

We should all know by now that sugary drinks are bad, even artificially sweetened ones. It might not always stop us from drinking them, but we know the deal. But what if sugary drinks like soda could be helpful for girls in school?

©sjlocke/istock.com

You read that right. We said girls. A soda before class might have boys bouncing off the walls, but not girls. A recent study showed that not only was girls’ behavior unaffected by having a sugary drink, their math skills even improved.

Researchers analyzed the behavior of 4- to 6-year-old children before and after having a sugary drink. The sugar rush was actually calming for girls and helped them perform better with numerical skills, but the opposite was true for boys. “Our study is the first to provide large-scale experimental evidence on the impact of sugary drinks on preschool children. The results clearly indicate a causal impact of sugary drinks on children’s behavior and test scores,” Fritz Schiltz, PhD, said in a written statement.

This probably isn’t the green light to have as many sugary drinks as you want, but it might be interesting to see how your work is affected after a soda.
 

 

 

Chicken nuggets and the meat paradox

Two young children are fighting over the last chicken nugget when an adult comes in to see what’s going on.

Liam: Vegetable!

Olivia: Meat!

Liam: Chicken nuggets are vegetables!

Olivia: No, dorkface! They’re meat.

Caregiver: Good news, kids. You’re both right.

Olivia: How can we both be right?

At this point, a woman enters the room. She’s wearing a white lab coat, so she must be a scientist.

Dr. Scientist: You can’t both be right, Olivia. You are being fed a serving of the meat paradox. That’s why Liam here doesn’t know that chicken nuggets are made of chicken, which is a form of meat. Sadly, he’s not the only one.

pxfuel

In a recent study, scientists from Furman University in Greenville, S.C., found that 38% of 176 children aged 4-7 years thought that chicken nuggets were vegetables and more than 46% identified French fries as animal based.

Olivia: Did our caregiver lie to us, Dr. Scientist?

Dr. Scientist: Yes, Olivia. The researchers I mentioned explained that “many people experience unease while eating meat. Omnivores eat foods that entail animal suffering and death while at the same time endorsing the compassionate treatment of animals.” That’s the meat paradox.

Liam: What else did they say, Dr. Scientist?

Dr. Scientist: Over 70% of those children said that cows and pigs were not edible and 5% thought that cats and horses were. The investigators wrote “that children and youth should be viewed as agents of environmental change” in the future, but suggested that parents need to bring honesty to the table.

Caregiver: How did you get in here anyway? And how do you know their names?

Dr. Scientist: I’ve been rooting through your garbage for years. All in the name of science, of course.

Bedtimes aren’t just for children

There are multiple ways to prevent heart disease, but what if it could be as easy as switching your bedtime? A recent study in European Heart Journal–Digital Health suggests that there’s a sweet spot when it comes to sleep timing.

Tumisu/Pixabay

Through smartwatch-like devices, researchers measured the sleep-onset and wake-up times for 7 days in 88,026 participants aged 43-79 years. After 5.7 years of follow-up to see if anyone had a heart attack, stroke, or any other cardiovascular event, 3.6% developed some kind of cardiovascular disease.

Those who went to bed between 10 p.m. and 11 p.m. had a lower risk of developing heart disease. The risk was 25% higher for subjects who went to bed at midnight or later, 24% higher for bedtimes before 10 p.m., and 12% higher for bedtimes between 11 p.m. and midnight.

So, why can you go to bed before “The Tonight Show” and lower your cardiovascular risk but not before the nightly news? Well, it has something to do with your body’s natural clock.

“The optimum time to go to sleep is at a specific point in the body’s 24-hour cycle and deviations may be detrimental to health. The riskiest time was after midnight, potentially because it may reduce the likelihood of seeing morning light, which resets the body clock,” said study author Dr. David Plans of the University of Exeter, England.

Although a sleep schedule is preferred, it isn’t realistic all the time for those in certain occupations who might have to resort to other methods to keep their circadian clocks ticking optimally for their health. But if all it takes is prescribing a sleep time to reduce heart disease on a massive scale it would make a great “low-cost public health target.”

So bedtimes aren’t just for children.

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Topics
Sections

 

The greatest autopsy on Earth?

The LOTME staff would like to apologize in advance. The following item contains historical facts.

P.T. Barnum is a rather controversial figure in American history. The greatest show on Earth was certainly popular in its day. However, Barnum got his start in 1835 by leasing a slave named Joyce Heth, an elderly Black woman who told vivid stories of caring for a young George Washington. He toured her around the country, advertising her as a 160-year-old woman who served as George Washington’s nanny. When Ms. Heth died the next year, Barnum sold tickets to the autopsy, charging the equivalent of $30 in today’s money.

fstop123/E+

When a doctor announced that Ms. Heth was actually 75-80 when she died, it caused great controversy in the press and ruined Barnum’s career. Wait, no, that’s not right. The opposite, actually. He weathered the storm, built his famous circus, and never again committed a hoax.

It’s difficult to quantify how wrong publicly dissecting a person and charging people to see said dissection is, but that was almost 200 years ago. At the very least, we can say that such terrible behavior is firmly in the distant past.

Oh wait.

David Saunders, a 98-year-old veteran of World War II and the Korean War, donated his body to science. His body, however, was purchased by DeathScience.org from a medical lab – with the buyer supposedly misleading the medical lab about its intentions, which was for use at the traveling Oddities and Curiosities Expo. Tickets went for up to $500 each to witness the public autopsy of Mr. Saunders’ body, which took place at a Marriott in Portland, Ore. It promised to be an exciting, all-day event from 9 a.m. to 4 p.m., with a break for lunch, of course. You can’t have an autopsy without a catered lunch.

Another public autopsy event was scheduled in Seattle but canceled after news of the first event broke. Oh, and for that extra little kick, Mr. Saunders died from COVID-19, meaning that all those paying customers were exposed.

P.T. Barnum is probably rolling over in his grave right now. His autopsy tickets were a bargain.
 

Go ahead, have that soda before math

We should all know by now that sugary drinks are bad, even artificially sweetened ones. It might not always stop us from drinking them, but we know the deal. But what if sugary drinks like soda could be helpful for girls in school?

©sjlocke/istock.com

You read that right. We said girls. A soda before class might have boys bouncing off the walls, but not girls. A recent study showed that not only was girls’ behavior unaffected by having a sugary drink, their math skills even improved.

Researchers analyzed the behavior of 4- to 6-year-old children before and after having a sugary drink. The sugar rush was actually calming for girls and helped them perform better with numerical skills, but the opposite was true for boys. “Our study is the first to provide large-scale experimental evidence on the impact of sugary drinks on preschool children. The results clearly indicate a causal impact of sugary drinks on children’s behavior and test scores,” Fritz Schiltz, PhD, said in a written statement.

This probably isn’t the green light to have as many sugary drinks as you want, but it might be interesting to see how your work is affected after a soda.
 

 

 

Chicken nuggets and the meat paradox

Two young children are fighting over the last chicken nugget when an adult comes in to see what’s going on.

Liam: Vegetable!

Olivia: Meat!

Liam: Chicken nuggets are vegetables!

Olivia: No, dorkface! They’re meat.

Caregiver: Good news, kids. You’re both right.

Olivia: How can we both be right?

At this point, a woman enters the room. She’s wearing a white lab coat, so she must be a scientist.

Dr. Scientist: You can’t both be right, Olivia. You are being fed a serving of the meat paradox. That’s why Liam here doesn’t know that chicken nuggets are made of chicken, which is a form of meat. Sadly, he’s not the only one.

pxfuel

In a recent study, scientists from Furman University in Greenville, S.C., found that 38% of 176 children aged 4-7 years thought that chicken nuggets were vegetables and more than 46% identified French fries as animal based.

Olivia: Did our caregiver lie to us, Dr. Scientist?

Dr. Scientist: Yes, Olivia. The researchers I mentioned explained that “many people experience unease while eating meat. Omnivores eat foods that entail animal suffering and death while at the same time endorsing the compassionate treatment of animals.” That’s the meat paradox.

Liam: What else did they say, Dr. Scientist?

Dr. Scientist: Over 70% of those children said that cows and pigs were not edible and 5% thought that cats and horses were. The investigators wrote “that children and youth should be viewed as agents of environmental change” in the future, but suggested that parents need to bring honesty to the table.

Caregiver: How did you get in here anyway? And how do you know their names?

Dr. Scientist: I’ve been rooting through your garbage for years. All in the name of science, of course.

Bedtimes aren’t just for children

There are multiple ways to prevent heart disease, but what if it could be as easy as switching your bedtime? A recent study in European Heart Journal–Digital Health suggests that there’s a sweet spot when it comes to sleep timing.

Tumisu/Pixabay

Through smartwatch-like devices, researchers measured the sleep-onset and wake-up times for 7 days in 88,026 participants aged 43-79 years. After 5.7 years of follow-up to see if anyone had a heart attack, stroke, or any other cardiovascular event, 3.6% developed some kind of cardiovascular disease.

Those who went to bed between 10 p.m. and 11 p.m. had a lower risk of developing heart disease. The risk was 25% higher for subjects who went to bed at midnight or later, 24% higher for bedtimes before 10 p.m., and 12% higher for bedtimes between 11 p.m. and midnight.

So, why can you go to bed before “The Tonight Show” and lower your cardiovascular risk but not before the nightly news? Well, it has something to do with your body’s natural clock.

“The optimum time to go to sleep is at a specific point in the body’s 24-hour cycle and deviations may be detrimental to health. The riskiest time was after midnight, potentially because it may reduce the likelihood of seeing morning light, which resets the body clock,” said study author Dr. David Plans of the University of Exeter, England.

Although a sleep schedule is preferred, it isn’t realistic all the time for those in certain occupations who might have to resort to other methods to keep their circadian clocks ticking optimally for their health. But if all it takes is prescribing a sleep time to reduce heart disease on a massive scale it would make a great “low-cost public health target.”

So bedtimes aren’t just for children.

 

The greatest autopsy on Earth?

The LOTME staff would like to apologize in advance. The following item contains historical facts.

P.T. Barnum is a rather controversial figure in American history. The greatest show on Earth was certainly popular in its day. However, Barnum got his start in 1835 by leasing a slave named Joyce Heth, an elderly Black woman who told vivid stories of caring for a young George Washington. He toured her around the country, advertising her as a 160-year-old woman who served as George Washington’s nanny. When Ms. Heth died the next year, Barnum sold tickets to the autopsy, charging the equivalent of $30 in today’s money.

fstop123/E+

When a doctor announced that Ms. Heth was actually 75-80 when she died, it caused great controversy in the press and ruined Barnum’s career. Wait, no, that’s not right. The opposite, actually. He weathered the storm, built his famous circus, and never again committed a hoax.

It’s difficult to quantify how wrong publicly dissecting a person and charging people to see said dissection is, but that was almost 200 years ago. At the very least, we can say that such terrible behavior is firmly in the distant past.

Oh wait.

David Saunders, a 98-year-old veteran of World War II and the Korean War, donated his body to science. His body, however, was purchased by DeathScience.org from a medical lab – with the buyer supposedly misleading the medical lab about its intentions, which was for use at the traveling Oddities and Curiosities Expo. Tickets went for up to $500 each to witness the public autopsy of Mr. Saunders’ body, which took place at a Marriott in Portland, Ore. It promised to be an exciting, all-day event from 9 a.m. to 4 p.m., with a break for lunch, of course. You can’t have an autopsy without a catered lunch.

Another public autopsy event was scheduled in Seattle but canceled after news of the first event broke. Oh, and for that extra little kick, Mr. Saunders died from COVID-19, meaning that all those paying customers were exposed.

P.T. Barnum is probably rolling over in his grave right now. His autopsy tickets were a bargain.
 

Go ahead, have that soda before math

We should all know by now that sugary drinks are bad, even artificially sweetened ones. It might not always stop us from drinking them, but we know the deal. But what if sugary drinks like soda could be helpful for girls in school?

©sjlocke/istock.com

You read that right. We said girls. A soda before class might have boys bouncing off the walls, but not girls. A recent study showed that not only was girls’ behavior unaffected by having a sugary drink, their math skills even improved.

Researchers analyzed the behavior of 4- to 6-year-old children before and after having a sugary drink. The sugar rush was actually calming for girls and helped them perform better with numerical skills, but the opposite was true for boys. “Our study is the first to provide large-scale experimental evidence on the impact of sugary drinks on preschool children. The results clearly indicate a causal impact of sugary drinks on children’s behavior and test scores,” Fritz Schiltz, PhD, said in a written statement.

This probably isn’t the green light to have as many sugary drinks as you want, but it might be interesting to see how your work is affected after a soda.
 

 

 

Chicken nuggets and the meat paradox

Two young children are fighting over the last chicken nugget when an adult comes in to see what’s going on.

Liam: Vegetable!

Olivia: Meat!

Liam: Chicken nuggets are vegetables!

Olivia: No, dorkface! They’re meat.

Caregiver: Good news, kids. You’re both right.

Olivia: How can we both be right?

At this point, a woman enters the room. She’s wearing a white lab coat, so she must be a scientist.

Dr. Scientist: You can’t both be right, Olivia. You are being fed a serving of the meat paradox. That’s why Liam here doesn’t know that chicken nuggets are made of chicken, which is a form of meat. Sadly, he’s not the only one.

pxfuel

In a recent study, scientists from Furman University in Greenville, S.C., found that 38% of 176 children aged 4-7 years thought that chicken nuggets were vegetables and more than 46% identified French fries as animal based.

Olivia: Did our caregiver lie to us, Dr. Scientist?

Dr. Scientist: Yes, Olivia. The researchers I mentioned explained that “many people experience unease while eating meat. Omnivores eat foods that entail animal suffering and death while at the same time endorsing the compassionate treatment of animals.” That’s the meat paradox.

Liam: What else did they say, Dr. Scientist?

Dr. Scientist: Over 70% of those children said that cows and pigs were not edible and 5% thought that cats and horses were. The investigators wrote “that children and youth should be viewed as agents of environmental change” in the future, but suggested that parents need to bring honesty to the table.

Caregiver: How did you get in here anyway? And how do you know their names?

Dr. Scientist: I’ve been rooting through your garbage for years. All in the name of science, of course.

Bedtimes aren’t just for children

There are multiple ways to prevent heart disease, but what if it could be as easy as switching your bedtime? A recent study in European Heart Journal–Digital Health suggests that there’s a sweet spot when it comes to sleep timing.

Tumisu/Pixabay

Through smartwatch-like devices, researchers measured the sleep-onset and wake-up times for 7 days in 88,026 participants aged 43-79 years. After 5.7 years of follow-up to see if anyone had a heart attack, stroke, or any other cardiovascular event, 3.6% developed some kind of cardiovascular disease.

Those who went to bed between 10 p.m. and 11 p.m. had a lower risk of developing heart disease. The risk was 25% higher for subjects who went to bed at midnight or later, 24% higher for bedtimes before 10 p.m., and 12% higher for bedtimes between 11 p.m. and midnight.

So, why can you go to bed before “The Tonight Show” and lower your cardiovascular risk but not before the nightly news? Well, it has something to do with your body’s natural clock.

“The optimum time to go to sleep is at a specific point in the body’s 24-hour cycle and deviations may be detrimental to health. The riskiest time was after midnight, potentially because it may reduce the likelihood of seeing morning light, which resets the body clock,” said study author Dr. David Plans of the University of Exeter, England.

Although a sleep schedule is preferred, it isn’t realistic all the time for those in certain occupations who might have to resort to other methods to keep their circadian clocks ticking optimally for their health. But if all it takes is prescribing a sleep time to reduce heart disease on a massive scale it would make a great “low-cost public health target.”

So bedtimes aren’t just for children.

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Pfizer seeks EUA expansion for COVID-19 booster

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Changed
Wed, 11/10/2021 - 15:11

Pfizer and its European partner BioNTech on Nov. 9 asked the U.S. government to expand emergency use authorization (EUA) to allow everybody over 18 to receive their COVID-19 booster shots.

If the request is approved, the broader use of Pfizer boosters would be a step toward President Biden’s goal of boosters for all adults. He announced the goal last August but backed off after some scientists said younger people may not need boosters, especially with large parts of the world unvaccinated.

Pfizer is submitting a study of booster effects on 10,000 people to make its case, according to The Associated Press.

This would be Pfizer’s second attempt. In September, a Food and Drug Administration advisory panel turned down Pfizer’s idea of booster shots for everybody over 18.

However, the committee recommended Pfizer booster shots for people 65 and over, essential workers, and people with underlying health conditions.

The FDA and the Centers for Disease Control and Prevention authorized the Pfizer booster for those other groups and later authorization was granted for the same groups with Moderna and Johnson & Johnson boosters. People who got the two-shot Pfizer or Moderna vaccines should get a booster 6 months after the second dose and people who got the one-dose J&J vaccine should get a booster 2 months later.

The pro-booster argument has strengthened because new data have come in from Israel that confirm boosters provide protection as vaccine effectiveness wanes over time, The Washington Post reported. Also, health officials are worried about a post-holiday surge and because COVID-19 case counts and deaths are not dropping in every part of the country, though they are declining overall, according to the The Post report.

The regulatory path for a booster-for-all application is unclear. The Post, citing two unnamed officials, said the FDA probably won’t send the Pfizer application to the FDA advisory committee this time because the committee has already had extensive discussions about boosters. If the FDA gives the green light, CDC Director Rochelle Walensky, MD, would have to make updated recommendations on boosters, The Post article noted.
 

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

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Pfizer and its European partner BioNTech on Nov. 9 asked the U.S. government to expand emergency use authorization (EUA) to allow everybody over 18 to receive their COVID-19 booster shots.

If the request is approved, the broader use of Pfizer boosters would be a step toward President Biden’s goal of boosters for all adults. He announced the goal last August but backed off after some scientists said younger people may not need boosters, especially with large parts of the world unvaccinated.

Pfizer is submitting a study of booster effects on 10,000 people to make its case, according to The Associated Press.

This would be Pfizer’s second attempt. In September, a Food and Drug Administration advisory panel turned down Pfizer’s idea of booster shots for everybody over 18.

However, the committee recommended Pfizer booster shots for people 65 and over, essential workers, and people with underlying health conditions.

The FDA and the Centers for Disease Control and Prevention authorized the Pfizer booster for those other groups and later authorization was granted for the same groups with Moderna and Johnson & Johnson boosters. People who got the two-shot Pfizer or Moderna vaccines should get a booster 6 months after the second dose and people who got the one-dose J&J vaccine should get a booster 2 months later.

The pro-booster argument has strengthened because new data have come in from Israel that confirm boosters provide protection as vaccine effectiveness wanes over time, The Washington Post reported. Also, health officials are worried about a post-holiday surge and because COVID-19 case counts and deaths are not dropping in every part of the country, though they are declining overall, according to the The Post report.

The regulatory path for a booster-for-all application is unclear. The Post, citing two unnamed officials, said the FDA probably won’t send the Pfizer application to the FDA advisory committee this time because the committee has already had extensive discussions about boosters. If the FDA gives the green light, CDC Director Rochelle Walensky, MD, would have to make updated recommendations on boosters, The Post article noted.
 

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

Pfizer and its European partner BioNTech on Nov. 9 asked the U.S. government to expand emergency use authorization (EUA) to allow everybody over 18 to receive their COVID-19 booster shots.

If the request is approved, the broader use of Pfizer boosters would be a step toward President Biden’s goal of boosters for all adults. He announced the goal last August but backed off after some scientists said younger people may not need boosters, especially with large parts of the world unvaccinated.

Pfizer is submitting a study of booster effects on 10,000 people to make its case, according to The Associated Press.

This would be Pfizer’s second attempt. In September, a Food and Drug Administration advisory panel turned down Pfizer’s idea of booster shots for everybody over 18.

However, the committee recommended Pfizer booster shots for people 65 and over, essential workers, and people with underlying health conditions.

The FDA and the Centers for Disease Control and Prevention authorized the Pfizer booster for those other groups and later authorization was granted for the same groups with Moderna and Johnson & Johnson boosters. People who got the two-shot Pfizer or Moderna vaccines should get a booster 6 months after the second dose and people who got the one-dose J&J vaccine should get a booster 2 months later.

The pro-booster argument has strengthened because new data have come in from Israel that confirm boosters provide protection as vaccine effectiveness wanes over time, The Washington Post reported. Also, health officials are worried about a post-holiday surge and because COVID-19 case counts and deaths are not dropping in every part of the country, though they are declining overall, according to the The Post report.

The regulatory path for a booster-for-all application is unclear. The Post, citing two unnamed officials, said the FDA probably won’t send the Pfizer application to the FDA advisory committee this time because the committee has already had extensive discussions about boosters. If the FDA gives the green light, CDC Director Rochelle Walensky, MD, would have to make updated recommendations on boosters, The Post article noted.
 

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

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Should you tell your doctor that you’re a doctor?

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Fri, 12/03/2021 - 12:41

Should doctors seeking healthcare disclose that they are a doctor? 

The question drew spirited debate when urologist Ashley Winter, MD, made a simple, straightforward request on Twitter: “If you are a doctor & you come to an appointment please tell me you are a doctor, not because I will treat you differently but because it’s easier to speak in jargon.”

She later added, “This doesn’t’ mean I would be less patient-focused or emotional with a physician or other [healthcare worker]. Just means that, instead of saying ‘you will have a catheter draining your urine to a bag,’ I can say, ‘you will have a Foley.’ ”

The Tweet followed an encounter with a patient who told Dr. Winter that he was a doctor only after she had gone to some length explaining a surgical procedure in lay terms.

“I explained the surgery, obviously assuming he was an intelligent adult, but using fully layman’s terms,” she said in an interview. The patient then told her that he was a doctor. “I guess I felt this embarrassment — I wouldn’t have treated him differently, but I just could have discussed the procedure with him in more professional terms.” 

“To some extent, it was my own fault,” she commented in an interview. “I didn’t take the time to ask [about his work] at the beginning of the consultation, but that’s a fine line, also,” added Dr. Winter, a urologist and sexual medicine physician in Portland, Ore.

“You know that patient is there because they want care from you and it’s not necessarily always at the forefront of importance to be asking them what they do for their work, but alternatively, if you don’t ask then you put them in this position where they have to find a way to go ahead and tell you.”

Several people chimed in on the thread to voice their thoughts on the matter. Some commiserated with Dr. Winter’s experience:

“I took care of a retired cardiologist in the hospital as a second-year resident and honest to god he let me ramble on ‘explaining’ his echo result and never told me. I found out a couple days later and wanted to die,” posted @MaddyAndrewsMD.

Another recalled a similarly embarrassing experience when she “went on and on” discussing headaches with a patient whose husband “was in the corner smirking.”

“They told my attending later [that the] husband was a retired FM doc who practiced medicine longer than I’ve been alive. I wanted to die,” posted @JSinghDO.

Many on the thread, though, were doctors and other healthcare professionals speaking as patients. Some said they didn’t want to disclose their status as a healthcare provider because they felt it affected the care they received.

For example, @drhelenrainford commented: “In my experience my care is less ‘caring’ when they know I am a [doctor]. I get spoken to like they are discussing a patient with me — no empathy just facts and difficult results just blurted out without consideration. Awful awful time as an inpatient …but that’s another story!”

@Dr_B_Ring said: “Nope – You and I speak different jargon – I would want you to speak to me like a human that doesn’t know your jargon. My ego would get in the way of asking about the acronyms I don’t know if you knew I was a fellow physician.”

Conversely, @lozzlemcfozzle said: “Honestly I prefer not to tell my Doctors — I’ve found people skip explanations assuming I ‘know,’ or seem a little nervous when I tell them!”

Others said they felt uncomfortable — pretentious, even — in announcing their status, or worried that they might come across as expecting special care.

“It’s such a tough needle to thread. Want to tell people early but not come off as demanding special treatment, but don’t want to wait too long and it seems like a trap,” said @MDaware.

Twitter user @MsBabyCatcher wrote: “I have a hard time doing this because I don’t want people to think I’m being pretentious or going to micromanage/dictate care.”

Replying to @MsBabyCatcher, @RedStethoscope wrote: “I used to think this too until I got [very poor] care a few times, and was advised by other doctor moms to ‘play the doctor card.’ I have gotten better/more compassionate care by making sure it’s clear that I’m a physician (which is junk, but here we are).”

Several of those responding used the words “tricky” and “awkward,” suggesting a common theme for doctors presenting as patients.

“I struggle with this. My 5-year-old broke her arm this weekend, we spent hours in the ED, of my own hospital, I never mentioned it because I didn’t want to get preferential care. But as they were explaining her type of fracture, it felt awkward and inefficient,” said @lindsay_petty.

To avoid the awkwardness, a number of respondents said they purposefully use medical jargon to open up a conversation rather than just offering up the information that they are a doctor.

Still others offered suggestions on how to broach the subject more directly when presenting as a patient:

‘”Just FYI I’m a X doc but I’m here because I really want your help and advice!” That’s what I usually do,” wrote @drcakefm.

@BeeSting14618 Tweeted: “I usually say ‘I know some of this but I’m here because I want YOUR guidance. Also I may ask dumb questions, and I’ll tell you if a question is asking your opinion or making a request.’”

A few others injected a bit of humor: “I just do the 14-part handshake that only doctors know. Is that not customary?” quipped @Branmiz25.

“Ah yes, that transmits the entire [history of present illness],” replied Dr. Winter.

Jokes aside, the topic is obviously one that touched on a shared experience among healthcare providers, Dr. Winter commented. The Twitter thread she started just “blew up.”

That’s typically a sign that the Tweet is relatable for a lot of people, she said.

“It’s definitely something that all of us as care providers and as patients understand. It’s a funny, awkward thing that can really change an interaction, so we probably all feel pretty strongly about our experiences related to that,” she added.

The debate begs the question: Is there a duty or ethical reason to disclose?

“I definitely think it is very reasonable to disclose that one is a medical professional to another doctor,” medical ethicist Charlotte Blease, PhD, said in an interview. “There are good reasons to believe doing so might make a difference to the quality of communication and transparency.”

If the ability to use medical terminology or jargon more freely improves patient understanding, autonomy, and shared decision-making, then it may be of benefit, said Dr. Blease, a Keane OpenNotes Scholar at Beth Israel Deaconess Medical Center in Boston.

 

 

“Since doctors should strive to communicate effectively with every patient and to respect their unique needs and level of understanding, then I see no reason to deny that one is a medic,” she added.”

Knowing how to share the information is another story.

“This is something that affects all of us as physicians — we’re going to be patients at some point, right?” Dr. Winter commented. “But I don’t think how to disclose that is something that was ever brought up in my medical training.”

“Maybe there should just be a discussion of this one day when people are in medical school — maybe in a professionalism course — to broach this topic or look at if there’s any literature on outcomes related to disclosure of status or what are best practices,” she suggested. 

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

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Should doctors seeking healthcare disclose that they are a doctor? 

The question drew spirited debate when urologist Ashley Winter, MD, made a simple, straightforward request on Twitter: “If you are a doctor & you come to an appointment please tell me you are a doctor, not because I will treat you differently but because it’s easier to speak in jargon.”

She later added, “This doesn’t’ mean I would be less patient-focused or emotional with a physician or other [healthcare worker]. Just means that, instead of saying ‘you will have a catheter draining your urine to a bag,’ I can say, ‘you will have a Foley.’ ”

The Tweet followed an encounter with a patient who told Dr. Winter that he was a doctor only after she had gone to some length explaining a surgical procedure in lay terms.

“I explained the surgery, obviously assuming he was an intelligent adult, but using fully layman’s terms,” she said in an interview. The patient then told her that he was a doctor. “I guess I felt this embarrassment — I wouldn’t have treated him differently, but I just could have discussed the procedure with him in more professional terms.” 

“To some extent, it was my own fault,” she commented in an interview. “I didn’t take the time to ask [about his work] at the beginning of the consultation, but that’s a fine line, also,” added Dr. Winter, a urologist and sexual medicine physician in Portland, Ore.

“You know that patient is there because they want care from you and it’s not necessarily always at the forefront of importance to be asking them what they do for their work, but alternatively, if you don’t ask then you put them in this position where they have to find a way to go ahead and tell you.”

Several people chimed in on the thread to voice their thoughts on the matter. Some commiserated with Dr. Winter’s experience:

“I took care of a retired cardiologist in the hospital as a second-year resident and honest to god he let me ramble on ‘explaining’ his echo result and never told me. I found out a couple days later and wanted to die,” posted @MaddyAndrewsMD.

Another recalled a similarly embarrassing experience when she “went on and on” discussing headaches with a patient whose husband “was in the corner smirking.”

“They told my attending later [that the] husband was a retired FM doc who practiced medicine longer than I’ve been alive. I wanted to die,” posted @JSinghDO.

Many on the thread, though, were doctors and other healthcare professionals speaking as patients. Some said they didn’t want to disclose their status as a healthcare provider because they felt it affected the care they received.

For example, @drhelenrainford commented: “In my experience my care is less ‘caring’ when they know I am a [doctor]. I get spoken to like they are discussing a patient with me — no empathy just facts and difficult results just blurted out without consideration. Awful awful time as an inpatient …but that’s another story!”

@Dr_B_Ring said: “Nope – You and I speak different jargon – I would want you to speak to me like a human that doesn’t know your jargon. My ego would get in the way of asking about the acronyms I don’t know if you knew I was a fellow physician.”

Conversely, @lozzlemcfozzle said: “Honestly I prefer not to tell my Doctors — I’ve found people skip explanations assuming I ‘know,’ or seem a little nervous when I tell them!”

Others said they felt uncomfortable — pretentious, even — in announcing their status, or worried that they might come across as expecting special care.

“It’s such a tough needle to thread. Want to tell people early but not come off as demanding special treatment, but don’t want to wait too long and it seems like a trap,” said @MDaware.

Twitter user @MsBabyCatcher wrote: “I have a hard time doing this because I don’t want people to think I’m being pretentious or going to micromanage/dictate care.”

Replying to @MsBabyCatcher, @RedStethoscope wrote: “I used to think this too until I got [very poor] care a few times, and was advised by other doctor moms to ‘play the doctor card.’ I have gotten better/more compassionate care by making sure it’s clear that I’m a physician (which is junk, but here we are).”

Several of those responding used the words “tricky” and “awkward,” suggesting a common theme for doctors presenting as patients.

“I struggle with this. My 5-year-old broke her arm this weekend, we spent hours in the ED, of my own hospital, I never mentioned it because I didn’t want to get preferential care. But as they were explaining her type of fracture, it felt awkward and inefficient,” said @lindsay_petty.

To avoid the awkwardness, a number of respondents said they purposefully use medical jargon to open up a conversation rather than just offering up the information that they are a doctor.

Still others offered suggestions on how to broach the subject more directly when presenting as a patient:

‘”Just FYI I’m a X doc but I’m here because I really want your help and advice!” That’s what I usually do,” wrote @drcakefm.

@BeeSting14618 Tweeted: “I usually say ‘I know some of this but I’m here because I want YOUR guidance. Also I may ask dumb questions, and I’ll tell you if a question is asking your opinion or making a request.’”

A few others injected a bit of humor: “I just do the 14-part handshake that only doctors know. Is that not customary?” quipped @Branmiz25.

“Ah yes, that transmits the entire [history of present illness],” replied Dr. Winter.

Jokes aside, the topic is obviously one that touched on a shared experience among healthcare providers, Dr. Winter commented. The Twitter thread she started just “blew up.”

That’s typically a sign that the Tweet is relatable for a lot of people, she said.

“It’s definitely something that all of us as care providers and as patients understand. It’s a funny, awkward thing that can really change an interaction, so we probably all feel pretty strongly about our experiences related to that,” she added.

The debate begs the question: Is there a duty or ethical reason to disclose?

“I definitely think it is very reasonable to disclose that one is a medical professional to another doctor,” medical ethicist Charlotte Blease, PhD, said in an interview. “There are good reasons to believe doing so might make a difference to the quality of communication and transparency.”

If the ability to use medical terminology or jargon more freely improves patient understanding, autonomy, and shared decision-making, then it may be of benefit, said Dr. Blease, a Keane OpenNotes Scholar at Beth Israel Deaconess Medical Center in Boston.

 

 

“Since doctors should strive to communicate effectively with every patient and to respect their unique needs and level of understanding, then I see no reason to deny that one is a medic,” she added.”

Knowing how to share the information is another story.

“This is something that affects all of us as physicians — we’re going to be patients at some point, right?” Dr. Winter commented. “But I don’t think how to disclose that is something that was ever brought up in my medical training.”

“Maybe there should just be a discussion of this one day when people are in medical school — maybe in a professionalism course — to broach this topic or look at if there’s any literature on outcomes related to disclosure of status or what are best practices,” she suggested. 

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

Should doctors seeking healthcare disclose that they are a doctor? 

The question drew spirited debate when urologist Ashley Winter, MD, made a simple, straightforward request on Twitter: “If you are a doctor & you come to an appointment please tell me you are a doctor, not because I will treat you differently but because it’s easier to speak in jargon.”

She later added, “This doesn’t’ mean I would be less patient-focused or emotional with a physician or other [healthcare worker]. Just means that, instead of saying ‘you will have a catheter draining your urine to a bag,’ I can say, ‘you will have a Foley.’ ”

The Tweet followed an encounter with a patient who told Dr. Winter that he was a doctor only after she had gone to some length explaining a surgical procedure in lay terms.

“I explained the surgery, obviously assuming he was an intelligent adult, but using fully layman’s terms,” she said in an interview. The patient then told her that he was a doctor. “I guess I felt this embarrassment — I wouldn’t have treated him differently, but I just could have discussed the procedure with him in more professional terms.” 

“To some extent, it was my own fault,” she commented in an interview. “I didn’t take the time to ask [about his work] at the beginning of the consultation, but that’s a fine line, also,” added Dr. Winter, a urologist and sexual medicine physician in Portland, Ore.

“You know that patient is there because they want care from you and it’s not necessarily always at the forefront of importance to be asking them what they do for their work, but alternatively, if you don’t ask then you put them in this position where they have to find a way to go ahead and tell you.”

Several people chimed in on the thread to voice their thoughts on the matter. Some commiserated with Dr. Winter’s experience:

“I took care of a retired cardiologist in the hospital as a second-year resident and honest to god he let me ramble on ‘explaining’ his echo result and never told me. I found out a couple days later and wanted to die,” posted @MaddyAndrewsMD.

Another recalled a similarly embarrassing experience when she “went on and on” discussing headaches with a patient whose husband “was in the corner smirking.”

“They told my attending later [that the] husband was a retired FM doc who practiced medicine longer than I’ve been alive. I wanted to die,” posted @JSinghDO.

Many on the thread, though, were doctors and other healthcare professionals speaking as patients. Some said they didn’t want to disclose their status as a healthcare provider because they felt it affected the care they received.

For example, @drhelenrainford commented: “In my experience my care is less ‘caring’ when they know I am a [doctor]. I get spoken to like they are discussing a patient with me — no empathy just facts and difficult results just blurted out without consideration. Awful awful time as an inpatient …but that’s another story!”

@Dr_B_Ring said: “Nope – You and I speak different jargon – I would want you to speak to me like a human that doesn’t know your jargon. My ego would get in the way of asking about the acronyms I don’t know if you knew I was a fellow physician.”

Conversely, @lozzlemcfozzle said: “Honestly I prefer not to tell my Doctors — I’ve found people skip explanations assuming I ‘know,’ or seem a little nervous when I tell them!”

Others said they felt uncomfortable — pretentious, even — in announcing their status, or worried that they might come across as expecting special care.

“It’s such a tough needle to thread. Want to tell people early but not come off as demanding special treatment, but don’t want to wait too long and it seems like a trap,” said @MDaware.

Twitter user @MsBabyCatcher wrote: “I have a hard time doing this because I don’t want people to think I’m being pretentious or going to micromanage/dictate care.”

Replying to @MsBabyCatcher, @RedStethoscope wrote: “I used to think this too until I got [very poor] care a few times, and was advised by other doctor moms to ‘play the doctor card.’ I have gotten better/more compassionate care by making sure it’s clear that I’m a physician (which is junk, but here we are).”

Several of those responding used the words “tricky” and “awkward,” suggesting a common theme for doctors presenting as patients.

“I struggle with this. My 5-year-old broke her arm this weekend, we spent hours in the ED, of my own hospital, I never mentioned it because I didn’t want to get preferential care. But as they were explaining her type of fracture, it felt awkward and inefficient,” said @lindsay_petty.

To avoid the awkwardness, a number of respondents said they purposefully use medical jargon to open up a conversation rather than just offering up the information that they are a doctor.

Still others offered suggestions on how to broach the subject more directly when presenting as a patient:

‘”Just FYI I’m a X doc but I’m here because I really want your help and advice!” That’s what I usually do,” wrote @drcakefm.

@BeeSting14618 Tweeted: “I usually say ‘I know some of this but I’m here because I want YOUR guidance. Also I may ask dumb questions, and I’ll tell you if a question is asking your opinion or making a request.’”

A few others injected a bit of humor: “I just do the 14-part handshake that only doctors know. Is that not customary?” quipped @Branmiz25.

“Ah yes, that transmits the entire [history of present illness],” replied Dr. Winter.

Jokes aside, the topic is obviously one that touched on a shared experience among healthcare providers, Dr. Winter commented. The Twitter thread she started just “blew up.”

That’s typically a sign that the Tweet is relatable for a lot of people, she said.

“It’s definitely something that all of us as care providers and as patients understand. It’s a funny, awkward thing that can really change an interaction, so we probably all feel pretty strongly about our experiences related to that,” she added.

The debate begs the question: Is there a duty or ethical reason to disclose?

“I definitely think it is very reasonable to disclose that one is a medical professional to another doctor,” medical ethicist Charlotte Blease, PhD, said in an interview. “There are good reasons to believe doing so might make a difference to the quality of communication and transparency.”

If the ability to use medical terminology or jargon more freely improves patient understanding, autonomy, and shared decision-making, then it may be of benefit, said Dr. Blease, a Keane OpenNotes Scholar at Beth Israel Deaconess Medical Center in Boston.

 

 

“Since doctors should strive to communicate effectively with every patient and to respect their unique needs and level of understanding, then I see no reason to deny that one is a medic,” she added.”

Knowing how to share the information is another story.

“This is something that affects all of us as physicians — we’re going to be patients at some point, right?” Dr. Winter commented. “But I don’t think how to disclose that is something that was ever brought up in my medical training.”

“Maybe there should just be a discussion of this one day when people are in medical school — maybe in a professionalism course — to broach this topic or look at if there’s any literature on outcomes related to disclosure of status or what are best practices,” she suggested. 

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

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Unvaccinated people 20 times more likely to die from COVID: Texas study

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Wed, 11/10/2021 - 12:25

During the month of September, Texans who weren’t vaccinated against COVID-19 were 20 times more likely to die from COVID-19 and related complications than those who were fully vaccinated, according to a new study from the Texas Department of State Health Services.

The data also showed that unvaccinated people were 13 times more likely to test positive for COVID-19 than people who were fully vaccinated.

“This analysis quantifies what we’ve known for months,” Jennifer Shuford, MD, the state’s chief epidemiologist, told The Dallas Morning News.

“The COVID-19 vaccines are doing an excellent job of protecting people from getting sick and from dying from COVID-19,” she said. “Vaccination remains the best way to keep yourself and the people close to you safe from this deadly disease.”

As part of the study, researchers analyzed electronic lab reports, death certificates, and state immunization records, with a particular focus on September when the contagious Delta variant surged across Texas. The research marks the state’s first statistical analysis of COVID-19 vaccinations in Texas and the effects, the newspaper reported.

The protective effect of vaccination was most noticeable among younger groups. During September, the risk of COVID-19 death was 23 times higher in unvaccinated people in their 30s and 55 times higher for unvaccinated people in their 40s.

In addition, there were fewer than 10 COVID-19 deaths in September among fully vaccinated people between ages 18-29, as compared with 339 deaths among unvaccinated people in the same age group.

Then, looking at a longer time period -- from Jan. 15 to Oct. 1 -- the researchers found that unvaccinated people were 45 times more likely to contract COVID-19 than fully vaccinated people. The protective effect of vaccination against infection was strong across all adult age groups but greatest among ages 12-17.

“All authorized COVID-19 vaccines in the United States are highly effective at protecting people from getting sick or severely ill with COVID-19, including those infected with Delta and other known variants,” the study authors wrote. “Real world data from Texas clearly shows these benefits.”

About 15.6 million people in Texas have been fully vaccinated against COVID-19 in a state of about 29 million residents, according to state data. About 66% of the population has received at least one dose, while 58% is fully vaccinated.

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

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During the month of September, Texans who weren’t vaccinated against COVID-19 were 20 times more likely to die from COVID-19 and related complications than those who were fully vaccinated, according to a new study from the Texas Department of State Health Services.

The data also showed that unvaccinated people were 13 times more likely to test positive for COVID-19 than people who were fully vaccinated.

“This analysis quantifies what we’ve known for months,” Jennifer Shuford, MD, the state’s chief epidemiologist, told The Dallas Morning News.

“The COVID-19 vaccines are doing an excellent job of protecting people from getting sick and from dying from COVID-19,” she said. “Vaccination remains the best way to keep yourself and the people close to you safe from this deadly disease.”

As part of the study, researchers analyzed electronic lab reports, death certificates, and state immunization records, with a particular focus on September when the contagious Delta variant surged across Texas. The research marks the state’s first statistical analysis of COVID-19 vaccinations in Texas and the effects, the newspaper reported.

The protective effect of vaccination was most noticeable among younger groups. During September, the risk of COVID-19 death was 23 times higher in unvaccinated people in their 30s and 55 times higher for unvaccinated people in their 40s.

In addition, there were fewer than 10 COVID-19 deaths in September among fully vaccinated people between ages 18-29, as compared with 339 deaths among unvaccinated people in the same age group.

Then, looking at a longer time period -- from Jan. 15 to Oct. 1 -- the researchers found that unvaccinated people were 45 times more likely to contract COVID-19 than fully vaccinated people. The protective effect of vaccination against infection was strong across all adult age groups but greatest among ages 12-17.

“All authorized COVID-19 vaccines in the United States are highly effective at protecting people from getting sick or severely ill with COVID-19, including those infected with Delta and other known variants,” the study authors wrote. “Real world data from Texas clearly shows these benefits.”

About 15.6 million people in Texas have been fully vaccinated against COVID-19 in a state of about 29 million residents, according to state data. About 66% of the population has received at least one dose, while 58% is fully vaccinated.

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

During the month of September, Texans who weren’t vaccinated against COVID-19 were 20 times more likely to die from COVID-19 and related complications than those who were fully vaccinated, according to a new study from the Texas Department of State Health Services.

The data also showed that unvaccinated people were 13 times more likely to test positive for COVID-19 than people who were fully vaccinated.

“This analysis quantifies what we’ve known for months,” Jennifer Shuford, MD, the state’s chief epidemiologist, told The Dallas Morning News.

“The COVID-19 vaccines are doing an excellent job of protecting people from getting sick and from dying from COVID-19,” she said. “Vaccination remains the best way to keep yourself and the people close to you safe from this deadly disease.”

As part of the study, researchers analyzed electronic lab reports, death certificates, and state immunization records, with a particular focus on September when the contagious Delta variant surged across Texas. The research marks the state’s first statistical analysis of COVID-19 vaccinations in Texas and the effects, the newspaper reported.

The protective effect of vaccination was most noticeable among younger groups. During September, the risk of COVID-19 death was 23 times higher in unvaccinated people in their 30s and 55 times higher for unvaccinated people in their 40s.

In addition, there were fewer than 10 COVID-19 deaths in September among fully vaccinated people between ages 18-29, as compared with 339 deaths among unvaccinated people in the same age group.

Then, looking at a longer time period -- from Jan. 15 to Oct. 1 -- the researchers found that unvaccinated people were 45 times more likely to contract COVID-19 than fully vaccinated people. The protective effect of vaccination against infection was strong across all adult age groups but greatest among ages 12-17.

“All authorized COVID-19 vaccines in the United States are highly effective at protecting people from getting sick or severely ill with COVID-19, including those infected with Delta and other known variants,” the study authors wrote. “Real world data from Texas clearly shows these benefits.”

About 15.6 million people in Texas have been fully vaccinated against COVID-19 in a state of about 29 million residents, according to state data. About 66% of the population has received at least one dose, while 58% is fully vaccinated.

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

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Electronic ‘nose’ sniffs out sarcoidosis

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Tue, 11/09/2021 - 15:21

An electronic nose (eNose) that measures volatile organic compounds (VOCs) emitted from the lungs successfully distinguished sarcoidosis from interstitial lung disease (ILD) and healthy controls, according to a report in the journal CHEST.

Dr. Iris van der Sar

The approach has the potential to generate clinical data that can’t be achieved through other noninvasive means, such as the serum biomarker soluble interleukin-2 receptor (sIL-2R). sIL-2R is often used to track disease activity, but it isn’t specific for diagnosing sarcoidosis, and it isn’t available worldwide.

Sarcoidosis is a granulomatous inflammatory disease with no known cause and can affect most organs, but an estimated 89%-99% of cases affect the lungs. There is no simple noninvasive diagnostic test, leaving physicians to rely on clinical features, biopsies to obtain tissue pathology, and the ruling out of other granulomatous diagnoses.

The challenge is more difficult because sarcoidosis is a heterogeneous disease, with great variation in the number of organs affected, severity, rate of progression, and response to therapy.

Previous researchers have used VOCs in an attempt to diagnose diseases, since the compounds reflect pathophysiological processes. Gas chromatography/mass spectrometry (GCMS) is one method to identify the individual VOCs, but the process is time consuming and complex. Some nevertheless showed potential in sarcoidosis, but failed to reproduce their performance in validation cohorts.

In the new study, a cross-sectional analysis showed that exhaled breath analysis using an eNose had excellent sensitivity and specificity for distinguishing sarcoidosis from ILD and healthy controls, and identified sarcoidosis regardless of pulmonary involvement, pulmonary fibrosis, multiple organ involvement, immunosuppressive treatment, or whether or not pathology supported the diagnosis.

Dr. Marlies Wijsenbeek

The eNose technology produces a “breath-print” after combining information from a broad range of VOCs. The information originates from an array of metal-oxide semiconductor sensors with partial specificity that artificial intelligence processes to discern patterns. Overall, the system functions similarly to the mammalian olfactory system. The artificial intelligence instead views it as a “breath-print” that it can compare against previously learned patterns.

“It is a quite easy, simple, and quick procedure, which is noninvasive. We can collect a lot of data from the VOCs in the exhaled breath because there are several sensors that cross-react. We can create breath profiles and group patients to see if profiles differ. Ultimately, we can use the profiles to diagnose or detect disease in the earlier stage and more accurately,” said Iris van der Sar, MD. Dr. van der Sar is the lead author on the study and a PhD candidate at Erasmus Medical Center in Rotterdam.

The study requires further prospective validation, but the technology could have important clinical benefits, said senior author and principal investigator Marlies Wijsenbeek, MD, PhD, pulmonologist and head of the Interstitial Lung Disease Center at Erasmus Medical Center. “If we in future can avoid a biopsy, that would be most attractive,” said Dr. Wijsenbeek.

“We hope to come to a point-of-care device that can be used to facilitate early diagnosis at low burden for the patient and health care system,” said Karen Moor, MD, PhD, and post-doc on this project. The researchers also hope to determine if the eNose can help evaluate a patient’s response to therapy.

Dr. Karen Moor

Studies of eNose technology in other chronic diseases have shown promising results, but not all results have been validated yet in independent or external cohorts.

The current study included 569 outpatients, 252 with sarcoidosis and 317 with ILD, along with 48 healthy controls. The researchers constructed a training set using 168 patients with sarcoidosis and 32 healthy controls, and a validation set using 84 patients with sarcoidosis and 16 healthy controls. The eNose differentiated between patients and controls in both groups, with an area under the curve of 1.00 for each regardless of pulmonary involvement or treatment.

It also distinguished those with sarcoidosis and pulmonary involvement from those with ILD, with an AUC of 0.90 (95% confidence interval, 0.87-0.94) in the training set, and an AUC of 0.87 (95% CI, 0.82-0.93) in the validation set.

It differentiated between pulmonary sarcoidosis and hypersensitivity pneumonitis in the training set (AUC 0.95; 95% CI, 0.90-0.99) and the validation set (AUC, 0.88; 95% CI, 0.75-1.00).

The study received no funding. Dr. Wijsenbeek, Dr. van der Sar, and Dr. Moor have no relevant financial disclosures.

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An electronic nose (eNose) that measures volatile organic compounds (VOCs) emitted from the lungs successfully distinguished sarcoidosis from interstitial lung disease (ILD) and healthy controls, according to a report in the journal CHEST.

Dr. Iris van der Sar

The approach has the potential to generate clinical data that can’t be achieved through other noninvasive means, such as the serum biomarker soluble interleukin-2 receptor (sIL-2R). sIL-2R is often used to track disease activity, but it isn’t specific for diagnosing sarcoidosis, and it isn’t available worldwide.

Sarcoidosis is a granulomatous inflammatory disease with no known cause and can affect most organs, but an estimated 89%-99% of cases affect the lungs. There is no simple noninvasive diagnostic test, leaving physicians to rely on clinical features, biopsies to obtain tissue pathology, and the ruling out of other granulomatous diagnoses.

The challenge is more difficult because sarcoidosis is a heterogeneous disease, with great variation in the number of organs affected, severity, rate of progression, and response to therapy.

Previous researchers have used VOCs in an attempt to diagnose diseases, since the compounds reflect pathophysiological processes. Gas chromatography/mass spectrometry (GCMS) is one method to identify the individual VOCs, but the process is time consuming and complex. Some nevertheless showed potential in sarcoidosis, but failed to reproduce their performance in validation cohorts.

In the new study, a cross-sectional analysis showed that exhaled breath analysis using an eNose had excellent sensitivity and specificity for distinguishing sarcoidosis from ILD and healthy controls, and identified sarcoidosis regardless of pulmonary involvement, pulmonary fibrosis, multiple organ involvement, immunosuppressive treatment, or whether or not pathology supported the diagnosis.

Dr. Marlies Wijsenbeek

The eNose technology produces a “breath-print” after combining information from a broad range of VOCs. The information originates from an array of metal-oxide semiconductor sensors with partial specificity that artificial intelligence processes to discern patterns. Overall, the system functions similarly to the mammalian olfactory system. The artificial intelligence instead views it as a “breath-print” that it can compare against previously learned patterns.

“It is a quite easy, simple, and quick procedure, which is noninvasive. We can collect a lot of data from the VOCs in the exhaled breath because there are several sensors that cross-react. We can create breath profiles and group patients to see if profiles differ. Ultimately, we can use the profiles to diagnose or detect disease in the earlier stage and more accurately,” said Iris van der Sar, MD. Dr. van der Sar is the lead author on the study and a PhD candidate at Erasmus Medical Center in Rotterdam.

The study requires further prospective validation, but the technology could have important clinical benefits, said senior author and principal investigator Marlies Wijsenbeek, MD, PhD, pulmonologist and head of the Interstitial Lung Disease Center at Erasmus Medical Center. “If we in future can avoid a biopsy, that would be most attractive,” said Dr. Wijsenbeek.

“We hope to come to a point-of-care device that can be used to facilitate early diagnosis at low burden for the patient and health care system,” said Karen Moor, MD, PhD, and post-doc on this project. The researchers also hope to determine if the eNose can help evaluate a patient’s response to therapy.

Dr. Karen Moor

Studies of eNose technology in other chronic diseases have shown promising results, but not all results have been validated yet in independent or external cohorts.

The current study included 569 outpatients, 252 with sarcoidosis and 317 with ILD, along with 48 healthy controls. The researchers constructed a training set using 168 patients with sarcoidosis and 32 healthy controls, and a validation set using 84 patients with sarcoidosis and 16 healthy controls. The eNose differentiated between patients and controls in both groups, with an area under the curve of 1.00 for each regardless of pulmonary involvement or treatment.

It also distinguished those with sarcoidosis and pulmonary involvement from those with ILD, with an AUC of 0.90 (95% confidence interval, 0.87-0.94) in the training set, and an AUC of 0.87 (95% CI, 0.82-0.93) in the validation set.

It differentiated between pulmonary sarcoidosis and hypersensitivity pneumonitis in the training set (AUC 0.95; 95% CI, 0.90-0.99) and the validation set (AUC, 0.88; 95% CI, 0.75-1.00).

The study received no funding. Dr. Wijsenbeek, Dr. van der Sar, and Dr. Moor have no relevant financial disclosures.

An electronic nose (eNose) that measures volatile organic compounds (VOCs) emitted from the lungs successfully distinguished sarcoidosis from interstitial lung disease (ILD) and healthy controls, according to a report in the journal CHEST.

Dr. Iris van der Sar

The approach has the potential to generate clinical data that can’t be achieved through other noninvasive means, such as the serum biomarker soluble interleukin-2 receptor (sIL-2R). sIL-2R is often used to track disease activity, but it isn’t specific for diagnosing sarcoidosis, and it isn’t available worldwide.

Sarcoidosis is a granulomatous inflammatory disease with no known cause and can affect most organs, but an estimated 89%-99% of cases affect the lungs. There is no simple noninvasive diagnostic test, leaving physicians to rely on clinical features, biopsies to obtain tissue pathology, and the ruling out of other granulomatous diagnoses.

The challenge is more difficult because sarcoidosis is a heterogeneous disease, with great variation in the number of organs affected, severity, rate of progression, and response to therapy.

Previous researchers have used VOCs in an attempt to diagnose diseases, since the compounds reflect pathophysiological processes. Gas chromatography/mass spectrometry (GCMS) is one method to identify the individual VOCs, but the process is time consuming and complex. Some nevertheless showed potential in sarcoidosis, but failed to reproduce their performance in validation cohorts.

In the new study, a cross-sectional analysis showed that exhaled breath analysis using an eNose had excellent sensitivity and specificity for distinguishing sarcoidosis from ILD and healthy controls, and identified sarcoidosis regardless of pulmonary involvement, pulmonary fibrosis, multiple organ involvement, immunosuppressive treatment, or whether or not pathology supported the diagnosis.

Dr. Marlies Wijsenbeek

The eNose technology produces a “breath-print” after combining information from a broad range of VOCs. The information originates from an array of metal-oxide semiconductor sensors with partial specificity that artificial intelligence processes to discern patterns. Overall, the system functions similarly to the mammalian olfactory system. The artificial intelligence instead views it as a “breath-print” that it can compare against previously learned patterns.

“It is a quite easy, simple, and quick procedure, which is noninvasive. We can collect a lot of data from the VOCs in the exhaled breath because there are several sensors that cross-react. We can create breath profiles and group patients to see if profiles differ. Ultimately, we can use the profiles to diagnose or detect disease in the earlier stage and more accurately,” said Iris van der Sar, MD. Dr. van der Sar is the lead author on the study and a PhD candidate at Erasmus Medical Center in Rotterdam.

The study requires further prospective validation, but the technology could have important clinical benefits, said senior author and principal investigator Marlies Wijsenbeek, MD, PhD, pulmonologist and head of the Interstitial Lung Disease Center at Erasmus Medical Center. “If we in future can avoid a biopsy, that would be most attractive,” said Dr. Wijsenbeek.

“We hope to come to a point-of-care device that can be used to facilitate early diagnosis at low burden for the patient and health care system,” said Karen Moor, MD, PhD, and post-doc on this project. The researchers also hope to determine if the eNose can help evaluate a patient’s response to therapy.

Dr. Karen Moor

Studies of eNose technology in other chronic diseases have shown promising results, but not all results have been validated yet in independent or external cohorts.

The current study included 569 outpatients, 252 with sarcoidosis and 317 with ILD, along with 48 healthy controls. The researchers constructed a training set using 168 patients with sarcoidosis and 32 healthy controls, and a validation set using 84 patients with sarcoidosis and 16 healthy controls. The eNose differentiated between patients and controls in both groups, with an area under the curve of 1.00 for each regardless of pulmonary involvement or treatment.

It also distinguished those with sarcoidosis and pulmonary involvement from those with ILD, with an AUC of 0.90 (95% confidence interval, 0.87-0.94) in the training set, and an AUC of 0.87 (95% CI, 0.82-0.93) in the validation set.

It differentiated between pulmonary sarcoidosis and hypersensitivity pneumonitis in the training set (AUC 0.95; 95% CI, 0.90-0.99) and the validation set (AUC, 0.88; 95% CI, 0.75-1.00).

The study received no funding. Dr. Wijsenbeek, Dr. van der Sar, and Dr. Moor have no relevant financial disclosures.

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As constituents clamor for ivermectin, Republican politicians embrace the cause

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Changed
Tue, 11/09/2021 - 13:24

When state senators in South Carolina held two hearings in September about COVID-19 treatments, they got an earful on the benefits of ivermectin — which many of the lawmakers echoed, sharing experiences of their own loved ones.

The demands for access to the drug were loud and insistent, despite federal regulators’ recent warning against using the drug to treat COVID.

Ivermectin is a generic drug  that has been used for decades to treat river blindness, scabies, and even head lice. Veterinarians also use it, in different formulations and dosages, to treat animals for parasites like worms.

At one of the South Carolina hearings, Pressley Stutts III reminded the panel that his father, a prominent GOP leader in the state, had died of COVID a month earlier. He believed ivermectin could have helped him. But doctors at the hospital wouldn’t discuss it.

“I went every bit as far as I could without getting myself thrown in jail trying to save my father’s life,” he told the panel, as lawmakers offered condolences.

“What is going on here?” he asked, with the passion in his voice growing. “My dad’s dead!”

The pleas to public officials have been building. And now politicians are beginning to act, largely to satisfy their conservative constituents.

After the pandemic began, scientists launched clinical trials to see if ivermectin could help as a treatment for COVID. Some are still ongoing. But providers in mainstream medicine have rejected it as a COVID treatment, citing the poor quality of the studies to date, and two notorious “preprint” studies that were circulated before they were peer-reviewed, and later taken off the internet because of inaccurate and flawed data.

On Aug. 26, the Centers for Disease Control and Prevention advised clinicians not to use ivermectin, citing insufficient evidence of benefit and pointing out that unauthorized use had led to accidental poisonings. Vaccination, the CDC reiterated, is still the best way to avoid serious illness and death from the coronavirus.

But many Americans remain convinced ivermectin could be beneficial, and some politicians appear to be listening to them.

“If we have medications out here that are working — or seem to be working — I think it’s absolutely horrible that we’re not trying them,” said Republican state Sen. Tom Corbin in South Carolina. He questioned doctors who had come to the Statehouse to counter efforts to move ivermectin into mainstream use.

The doctors challenged the implied insult that they weren’t following best practices: “Any implication that any of us would do anything to withhold effective treatments from our patients is really insulting to our profession,” said Dr. Annie Andrews, a professor at the Medical University of South Carolina who has cared for COVID patients throughout the pandemic.

Instead of listening to the medical consensus, some politicians in states like South Carolina seem to be taking cues from doctors on the fringe. During one September hearing, state senators patched in a call from Dr. Pierre Kory.

 

 


Last year, Dr. Kory started a nonprofit called the Front Line COVID-19 Critical Care Alliance, which promotes ivermectin. He said he’s not making money by prescribing the drug, though the nonprofit does solicit donations and has not yet filed required financial documents with the IRS.

Dr. Kory acknowledged his medical opinions have landed him on “an island.”

He first testified about ivermectin to a U.S. Senate committee in December. That video went viral. Although it was taken down by YouTube, his Senate testimony prompted patients across the country to ask for ivermectin when they fell ill.

By late August, outpatient prescriptions had jumped 24-fold. Calls to poison control hotlines had tripled, mostly related to people taking ivermectin formulations meant for livestock.

Dr. Kory said he has effectively lost two jobs over his views on ivermectin. At his current hospital in Wisconsin, where he runs the intensive care unit two weeks a month, managers called him to a meeting in September, where he was informed he could no longer prescribe ivermectin. He’d been giving it to “every patient with COVID,” he said.

“After the pharma-geddon that was unleashed, yeah, they shut it down,” he told the South Carolina lawmakers. “And I will tell you that many hospitals across the country had already shut it down months ago.”

Framing the ivermectin fight as a battle against faceless federal agencies and big pharmaceutical corporations appealed to Americans already suspicious of the science behind the pandemic and the approved COVID vaccines.

Dr. Kory suggests success stories with COVID treatments in other parts of the world have been suppressed to instead promote the vaccines.

In an interview with NPR, Dr. Kory said he regrets the flashpoint he helped ignite.

“I feel really bad for the patients, and I feel really bad for the doctors,” he told NPR. “Both of them — both the patients and doctors — are trapped.”

Patients are still demanding the treatment, but doctors sympathetic to their wishes are being told by their health systems not to try it.

Now conservatives in elected office are sensing political payoff if they step in to help patients get the drug. State legislatures, including those in Tennessee and Alaska, are debating various ways to increase access to ivermectin — with proposals such as shielding doctors from repercussions for prescribing it, or forcing pharmacists to fill questionable prescriptions.

The Montana State News Bureau reported that the state’s Republican attorney general dispatched a state trooper to a hospital in Helena where a politically connected patient was dying of COVID. Her family was asking for ivermectin.

In a statement, St. Peter’s Hospital  said doctors and nurses were “harassed and threatened by three public officials.”

“These officials have no medical training or experience, yet they were insisting our providers give treatments for COVID-19 that are not authorized, clinically approved, or within the guidelines established by the FDA and the CDC,” the statement added.
 

 



On Oct. 14, the Republican attorney general in Nebraska addressed the controversy, issuing a nearly 50-page legal opinion arguing that doctors who consider the “off-label” use of ivermectin and hydroxychloroquine for COVID are acting within the parameters of their state medical licenses, as long as the physician obtains appropriate informed consent from a patient.

Some patients have filed lawsuits to obtain ivermectin, with mixed success. A patient in Illinois was denied. But other hospitals, including one in Ohio, have been forced to administer the drug against the objections of their physicians.

Even as they gain powerful political supporters, some ivermectin fans say they’re now avoiding the health care system — because they’ve lost faith in it.

Lesa Berry, of Richmond, Va., had a friend who died earlier this year of COVID. The doctors refused to use ivermectin, despite requests from Ms. Berry and the patient’s daughter.

They know better now, she said.

“My first attempt would have been to keep her out of the hospital,” Ms. Berry said. “Because right now when you go to the hospital, they only give you what’s on the CDC protocol.”

Ms. Berry and her husband have purchased their own supply of ivermectin, which they keep at home.

This story is from a partnership that includes NPRNashville Public Radio and  KHN. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

 

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When state senators in South Carolina held two hearings in September about COVID-19 treatments, they got an earful on the benefits of ivermectin — which many of the lawmakers echoed, sharing experiences of their own loved ones.

The demands for access to the drug were loud and insistent, despite federal regulators’ recent warning against using the drug to treat COVID.

Ivermectin is a generic drug  that has been used for decades to treat river blindness, scabies, and even head lice. Veterinarians also use it, in different formulations and dosages, to treat animals for parasites like worms.

At one of the South Carolina hearings, Pressley Stutts III reminded the panel that his father, a prominent GOP leader in the state, had died of COVID a month earlier. He believed ivermectin could have helped him. But doctors at the hospital wouldn’t discuss it.

“I went every bit as far as I could without getting myself thrown in jail trying to save my father’s life,” he told the panel, as lawmakers offered condolences.

“What is going on here?” he asked, with the passion in his voice growing. “My dad’s dead!”

The pleas to public officials have been building. And now politicians are beginning to act, largely to satisfy their conservative constituents.

After the pandemic began, scientists launched clinical trials to see if ivermectin could help as a treatment for COVID. Some are still ongoing. But providers in mainstream medicine have rejected it as a COVID treatment, citing the poor quality of the studies to date, and two notorious “preprint” studies that were circulated before they were peer-reviewed, and later taken off the internet because of inaccurate and flawed data.

On Aug. 26, the Centers for Disease Control and Prevention advised clinicians not to use ivermectin, citing insufficient evidence of benefit and pointing out that unauthorized use had led to accidental poisonings. Vaccination, the CDC reiterated, is still the best way to avoid serious illness and death from the coronavirus.

But many Americans remain convinced ivermectin could be beneficial, and some politicians appear to be listening to them.

“If we have medications out here that are working — or seem to be working — I think it’s absolutely horrible that we’re not trying them,” said Republican state Sen. Tom Corbin in South Carolina. He questioned doctors who had come to the Statehouse to counter efforts to move ivermectin into mainstream use.

The doctors challenged the implied insult that they weren’t following best practices: “Any implication that any of us would do anything to withhold effective treatments from our patients is really insulting to our profession,” said Dr. Annie Andrews, a professor at the Medical University of South Carolina who has cared for COVID patients throughout the pandemic.

Instead of listening to the medical consensus, some politicians in states like South Carolina seem to be taking cues from doctors on the fringe. During one September hearing, state senators patched in a call from Dr. Pierre Kory.

 

 


Last year, Dr. Kory started a nonprofit called the Front Line COVID-19 Critical Care Alliance, which promotes ivermectin. He said he’s not making money by prescribing the drug, though the nonprofit does solicit donations and has not yet filed required financial documents with the IRS.

Dr. Kory acknowledged his medical opinions have landed him on “an island.”

He first testified about ivermectin to a U.S. Senate committee in December. That video went viral. Although it was taken down by YouTube, his Senate testimony prompted patients across the country to ask for ivermectin when they fell ill.

By late August, outpatient prescriptions had jumped 24-fold. Calls to poison control hotlines had tripled, mostly related to people taking ivermectin formulations meant for livestock.

Dr. Kory said he has effectively lost two jobs over his views on ivermectin. At his current hospital in Wisconsin, where he runs the intensive care unit two weeks a month, managers called him to a meeting in September, where he was informed he could no longer prescribe ivermectin. He’d been giving it to “every patient with COVID,” he said.

“After the pharma-geddon that was unleashed, yeah, they shut it down,” he told the South Carolina lawmakers. “And I will tell you that many hospitals across the country had already shut it down months ago.”

Framing the ivermectin fight as a battle against faceless federal agencies and big pharmaceutical corporations appealed to Americans already suspicious of the science behind the pandemic and the approved COVID vaccines.

Dr. Kory suggests success stories with COVID treatments in other parts of the world have been suppressed to instead promote the vaccines.

In an interview with NPR, Dr. Kory said he regrets the flashpoint he helped ignite.

“I feel really bad for the patients, and I feel really bad for the doctors,” he told NPR. “Both of them — both the patients and doctors — are trapped.”

Patients are still demanding the treatment, but doctors sympathetic to their wishes are being told by their health systems not to try it.

Now conservatives in elected office are sensing political payoff if they step in to help patients get the drug. State legislatures, including those in Tennessee and Alaska, are debating various ways to increase access to ivermectin — with proposals such as shielding doctors from repercussions for prescribing it, or forcing pharmacists to fill questionable prescriptions.

The Montana State News Bureau reported that the state’s Republican attorney general dispatched a state trooper to a hospital in Helena where a politically connected patient was dying of COVID. Her family was asking for ivermectin.

In a statement, St. Peter’s Hospital  said doctors and nurses were “harassed and threatened by three public officials.”

“These officials have no medical training or experience, yet they were insisting our providers give treatments for COVID-19 that are not authorized, clinically approved, or within the guidelines established by the FDA and the CDC,” the statement added.
 

 



On Oct. 14, the Republican attorney general in Nebraska addressed the controversy, issuing a nearly 50-page legal opinion arguing that doctors who consider the “off-label” use of ivermectin and hydroxychloroquine for COVID are acting within the parameters of their state medical licenses, as long as the physician obtains appropriate informed consent from a patient.

Some patients have filed lawsuits to obtain ivermectin, with mixed success. A patient in Illinois was denied. But other hospitals, including one in Ohio, have been forced to administer the drug against the objections of their physicians.

Even as they gain powerful political supporters, some ivermectin fans say they’re now avoiding the health care system — because they’ve lost faith in it.

Lesa Berry, of Richmond, Va., had a friend who died earlier this year of COVID. The doctors refused to use ivermectin, despite requests from Ms. Berry and the patient’s daughter.

They know better now, she said.

“My first attempt would have been to keep her out of the hospital,” Ms. Berry said. “Because right now when you go to the hospital, they only give you what’s on the CDC protocol.”

Ms. Berry and her husband have purchased their own supply of ivermectin, which they keep at home.

This story is from a partnership that includes NPRNashville Public Radio and  KHN. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

 

When state senators in South Carolina held two hearings in September about COVID-19 treatments, they got an earful on the benefits of ivermectin — which many of the lawmakers echoed, sharing experiences of their own loved ones.

The demands for access to the drug were loud and insistent, despite federal regulators’ recent warning against using the drug to treat COVID.

Ivermectin is a generic drug  that has been used for decades to treat river blindness, scabies, and even head lice. Veterinarians also use it, in different formulations and dosages, to treat animals for parasites like worms.

At one of the South Carolina hearings, Pressley Stutts III reminded the panel that his father, a prominent GOP leader in the state, had died of COVID a month earlier. He believed ivermectin could have helped him. But doctors at the hospital wouldn’t discuss it.

“I went every bit as far as I could without getting myself thrown in jail trying to save my father’s life,” he told the panel, as lawmakers offered condolences.

“What is going on here?” he asked, with the passion in his voice growing. “My dad’s dead!”

The pleas to public officials have been building. And now politicians are beginning to act, largely to satisfy their conservative constituents.

After the pandemic began, scientists launched clinical trials to see if ivermectin could help as a treatment for COVID. Some are still ongoing. But providers in mainstream medicine have rejected it as a COVID treatment, citing the poor quality of the studies to date, and two notorious “preprint” studies that were circulated before they were peer-reviewed, and later taken off the internet because of inaccurate and flawed data.

On Aug. 26, the Centers for Disease Control and Prevention advised clinicians not to use ivermectin, citing insufficient evidence of benefit and pointing out that unauthorized use had led to accidental poisonings. Vaccination, the CDC reiterated, is still the best way to avoid serious illness and death from the coronavirus.

But many Americans remain convinced ivermectin could be beneficial, and some politicians appear to be listening to them.

“If we have medications out here that are working — or seem to be working — I think it’s absolutely horrible that we’re not trying them,” said Republican state Sen. Tom Corbin in South Carolina. He questioned doctors who had come to the Statehouse to counter efforts to move ivermectin into mainstream use.

The doctors challenged the implied insult that they weren’t following best practices: “Any implication that any of us would do anything to withhold effective treatments from our patients is really insulting to our profession,” said Dr. Annie Andrews, a professor at the Medical University of South Carolina who has cared for COVID patients throughout the pandemic.

Instead of listening to the medical consensus, some politicians in states like South Carolina seem to be taking cues from doctors on the fringe. During one September hearing, state senators patched in a call from Dr. Pierre Kory.

 

 


Last year, Dr. Kory started a nonprofit called the Front Line COVID-19 Critical Care Alliance, which promotes ivermectin. He said he’s not making money by prescribing the drug, though the nonprofit does solicit donations and has not yet filed required financial documents with the IRS.

Dr. Kory acknowledged his medical opinions have landed him on “an island.”

He first testified about ivermectin to a U.S. Senate committee in December. That video went viral. Although it was taken down by YouTube, his Senate testimony prompted patients across the country to ask for ivermectin when they fell ill.

By late August, outpatient prescriptions had jumped 24-fold. Calls to poison control hotlines had tripled, mostly related to people taking ivermectin formulations meant for livestock.

Dr. Kory said he has effectively lost two jobs over his views on ivermectin. At his current hospital in Wisconsin, where he runs the intensive care unit two weeks a month, managers called him to a meeting in September, where he was informed he could no longer prescribe ivermectin. He’d been giving it to “every patient with COVID,” he said.

“After the pharma-geddon that was unleashed, yeah, they shut it down,” he told the South Carolina lawmakers. “And I will tell you that many hospitals across the country had already shut it down months ago.”

Framing the ivermectin fight as a battle against faceless federal agencies and big pharmaceutical corporations appealed to Americans already suspicious of the science behind the pandemic and the approved COVID vaccines.

Dr. Kory suggests success stories with COVID treatments in other parts of the world have been suppressed to instead promote the vaccines.

In an interview with NPR, Dr. Kory said he regrets the flashpoint he helped ignite.

“I feel really bad for the patients, and I feel really bad for the doctors,” he told NPR. “Both of them — both the patients and doctors — are trapped.”

Patients are still demanding the treatment, but doctors sympathetic to their wishes are being told by their health systems not to try it.

Now conservatives in elected office are sensing political payoff if they step in to help patients get the drug. State legislatures, including those in Tennessee and Alaska, are debating various ways to increase access to ivermectin — with proposals such as shielding doctors from repercussions for prescribing it, or forcing pharmacists to fill questionable prescriptions.

The Montana State News Bureau reported that the state’s Republican attorney general dispatched a state trooper to a hospital in Helena where a politically connected patient was dying of COVID. Her family was asking for ivermectin.

In a statement, St. Peter’s Hospital  said doctors and nurses were “harassed and threatened by three public officials.”

“These officials have no medical training or experience, yet they were insisting our providers give treatments for COVID-19 that are not authorized, clinically approved, or within the guidelines established by the FDA and the CDC,” the statement added.
 

 



On Oct. 14, the Republican attorney general in Nebraska addressed the controversy, issuing a nearly 50-page legal opinion arguing that doctors who consider the “off-label” use of ivermectin and hydroxychloroquine for COVID are acting within the parameters of their state medical licenses, as long as the physician obtains appropriate informed consent from a patient.

Some patients have filed lawsuits to obtain ivermectin, with mixed success. A patient in Illinois was denied. But other hospitals, including one in Ohio, have been forced to administer the drug against the objections of their physicians.

Even as they gain powerful political supporters, some ivermectin fans say they’re now avoiding the health care system — because they’ve lost faith in it.

Lesa Berry, of Richmond, Va., had a friend who died earlier this year of COVID. The doctors refused to use ivermectin, despite requests from Ms. Berry and the patient’s daughter.

They know better now, she said.

“My first attempt would have been to keep her out of the hospital,” Ms. Berry said. “Because right now when you go to the hospital, they only give you what’s on the CDC protocol.”

Ms. Berry and her husband have purchased their own supply of ivermectin, which they keep at home.

This story is from a partnership that includes NPRNashville Public Radio and  KHN. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

 

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Genotype, need for transfusion predict death in VEXAS syndrome

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Tue, 11/09/2021 - 12:24

Among patients with the recently defined severe autoinflammatory syndrome VEXAS, those who are transfusion dependent or have a specific amino acid substitution are at highest risk for death, whereas those with ear chondritis are at significantly lower risk, a multinational team of investigators has found.

Courtesy Dr. Marcela Ferrada
Auricular chondritis in a man with VEXAS

Their study of mortality and predictors of survival among patients with genetically confirmed VEXAS showed that patients with a VEXAS variant resulting in an amino acid substitution of a methionine for a valine had a 3.5-fold higher risk for death, compared with patients with either a methionine-to-threonine substitution or a methionine-to-leucine swap.

Transfusion dependence was an independent predictor of mortality. Patients who became dependent on transfusions after symptom onset had a nearly threefold higher risk for death, reported Marcela A. Ferrada, MD, a clinical fellow at the National Institute of Arthritis and Musculoskeletal and Skin Diseases.

“These findings should inform risk assessment and clinical management in patients with VEXAS syndrome,” she said in an oral abstract presentation during the virtual annual meeting of the American College of Rheumatology.

“These genetic findings have proven right now to be not only diagnostic, but we have shown that they’re also prognostic, and we hope that this is going to help us identify patients who could have more aggressive treatment,” Dr. Ferrada said.



She also discussed her findings in a media briefing held 2 days prior to her plenary presentation. At that briefing, this news organization asked participating clinicians whether they had patients who they suspected may have had undiagnosed VEXAS.

“My answer to that is interesting,” replied moderator Vaneet Sandhu, MD, from Loma Linda (Calif.) University and Riverside University Health System.

“In the last couple of days, I’ve been reading about VEXAS, and actually texted one of my colleagues yesterday and said, ‘Hey, you know these patients we’ve been seeing who have these strange rashes and chondritis and have maybe a diagnosis of leukocytoclastic vasculitis or something else – are we not diagnosing these patients?’ ” she said.

“I think we are looking at every patient with chondritis and reexamining their phenotype. We had dismissed certain symptoms because they didn’t fit the archetype for relapsing polychondritis, for example, but it could be VEXAS,” said Alfred Kim, MD, PhD, of Washington University in St. Louis, who also presented data during the briefing.

Three variants

VEXAS is caused by somatic mutations in UBA1, a gene that initiates cytoplasmic ubiquitylation, a process by which misfolded proteins are tagged for degradation.

The syndrome’s name is an acronym descriptive of the major features:

  • Vacuoles in bone marrow cells.
  • E-1 activating enzyme that UBA1 encodes for.
  • X-linked.
  • Autoinflammatory.
  • Somatic mutation featuring hematologic mosaicism.

VEXAS results in rheumatologic, dermatologic, and hematologic symptoms that are often misdiagnosed as being caused by treatment-refractory relapsing polychondritis, polyarteritis nodosa, Sweet syndrome, giant cell arteritis, or myelodysplastic syndrome (MDS).

VEXAS was identified as a distinct syndrome within the past year by Dr. Ferrada and other investigators at NIAMS, the National Human Genome Research Institute, and other institutions.

In the study reported at ACR 2021, Dr. Ferrada and colleagues assessed 83 men who had been referred for genetic testing for VEXAS at the National Institutes of Health, in Bethesda, Md., and at Leeds (England) Teaching Hospitals NHS Trust.

All patients were confirmed to have VEXAS-defining genetic mutations in UBA1 by Sanger sequencing of peripheral blood samples. Only those patients with mutations at codon p.Met41 were included in the investigators’ analysis. Mutations at that site account for nearly all cases of VEXAS that have been identified to date.

The most common clinical manifestation of VEXAS was skin involvement, which occurred in all but one of the 83 patients. Other common manifestations included arthritis (58 patients), pulmonary infiltrates (57 patients), and ear chondritis (54 patients).



Fifteen patients were found to have the leucine variant, 18 had the valine variant, and 50 had the threonine variant. The median age at disease onset was 66 years in the leucine and threonine variant groups and 65 in the valine variant group.

The clinical diagnosis differed according to genotype: 4 of 18 patients (22%) with the valine variant were diagnosed with relapsing polychondritis, compared with 8 of 15 (53%) with the leucine variant and 31 of 50 (62%) with the threonine variant (P = .01).

In contrast, 55% of patients with valine genotype were diagnosed with undifferentiated fever, compared with 6% of those with the leucine and 16% with the threonine genotypes (P = .001). More patients with the leucine variant (60%) were diagnosed with Sweet syndrome, compared with 11% and 14% of patients with the valine and threonine variants, respectively (P = .001).

There was no significant difference among the three genotypes in the percentage of patients diagnosed with MDS.

The follow-up period ranged from 1 to 18 years (median, 4.7 years). The median survival time from disease onset for all patients was 10 years.

Among patients with the valine variant, median survival was 9 years, which was significantly less than among patients with the other two variants (P = .01).

In univariable analysis, independent predictors of mortality were ear chondritis (hazard ratio, 0.26; P = .005), transfusion dependence, a time-dependent variable (HR, 2.59; P = .03), and the valine variant (HR, 3.5; P = .008).

The association between VEXAS genotype and phenotype could be explained by the finding that, among patients with the valine variant, there was significantly less translation of the catalytically proficient UBA1b isoform than in patients with the other two variants, Dr. Ferrada said.

Therapeutic options

Dr. Ferrada noted that to date no drugs have been shown to provide consistent therapeutic benefits for patients with VEXAS, but evidence as to the etiology of the syndrome points to possible treatment approaches.

“All of these findings I think are extremely important to help us guide management of these patients, as we know that the mutation is located in the stem cells in the bone marrow. So we suspect that doing a bone marrow transplant in these patients is going to be curative,” Dr. Ferrada said during the briefing.

Investigators are planning a phase 2 trial of allogeneic hematopoietic stem cell transplant for patients with VEXAS.

The study was supported by the National Institutes of Health. Dr. Ferrada, Dr. Sandhu, and Dr. Kim have disclosed no relevant financial relationships.

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

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Among patients with the recently defined severe autoinflammatory syndrome VEXAS, those who are transfusion dependent or have a specific amino acid substitution are at highest risk for death, whereas those with ear chondritis are at significantly lower risk, a multinational team of investigators has found.

Courtesy Dr. Marcela Ferrada
Auricular chondritis in a man with VEXAS

Their study of mortality and predictors of survival among patients with genetically confirmed VEXAS showed that patients with a VEXAS variant resulting in an amino acid substitution of a methionine for a valine had a 3.5-fold higher risk for death, compared with patients with either a methionine-to-threonine substitution or a methionine-to-leucine swap.

Transfusion dependence was an independent predictor of mortality. Patients who became dependent on transfusions after symptom onset had a nearly threefold higher risk for death, reported Marcela A. Ferrada, MD, a clinical fellow at the National Institute of Arthritis and Musculoskeletal and Skin Diseases.

“These findings should inform risk assessment and clinical management in patients with VEXAS syndrome,” she said in an oral abstract presentation during the virtual annual meeting of the American College of Rheumatology.

“These genetic findings have proven right now to be not only diagnostic, but we have shown that they’re also prognostic, and we hope that this is going to help us identify patients who could have more aggressive treatment,” Dr. Ferrada said.



She also discussed her findings in a media briefing held 2 days prior to her plenary presentation. At that briefing, this news organization asked participating clinicians whether they had patients who they suspected may have had undiagnosed VEXAS.

“My answer to that is interesting,” replied moderator Vaneet Sandhu, MD, from Loma Linda (Calif.) University and Riverside University Health System.

“In the last couple of days, I’ve been reading about VEXAS, and actually texted one of my colleagues yesterday and said, ‘Hey, you know these patients we’ve been seeing who have these strange rashes and chondritis and have maybe a diagnosis of leukocytoclastic vasculitis or something else – are we not diagnosing these patients?’ ” she said.

“I think we are looking at every patient with chondritis and reexamining their phenotype. We had dismissed certain symptoms because they didn’t fit the archetype for relapsing polychondritis, for example, but it could be VEXAS,” said Alfred Kim, MD, PhD, of Washington University in St. Louis, who also presented data during the briefing.

Three variants

VEXAS is caused by somatic mutations in UBA1, a gene that initiates cytoplasmic ubiquitylation, a process by which misfolded proteins are tagged for degradation.

The syndrome’s name is an acronym descriptive of the major features:

  • Vacuoles in bone marrow cells.
  • E-1 activating enzyme that UBA1 encodes for.
  • X-linked.
  • Autoinflammatory.
  • Somatic mutation featuring hematologic mosaicism.

VEXAS results in rheumatologic, dermatologic, and hematologic symptoms that are often misdiagnosed as being caused by treatment-refractory relapsing polychondritis, polyarteritis nodosa, Sweet syndrome, giant cell arteritis, or myelodysplastic syndrome (MDS).

VEXAS was identified as a distinct syndrome within the past year by Dr. Ferrada and other investigators at NIAMS, the National Human Genome Research Institute, and other institutions.

In the study reported at ACR 2021, Dr. Ferrada and colleagues assessed 83 men who had been referred for genetic testing for VEXAS at the National Institutes of Health, in Bethesda, Md., and at Leeds (England) Teaching Hospitals NHS Trust.

All patients were confirmed to have VEXAS-defining genetic mutations in UBA1 by Sanger sequencing of peripheral blood samples. Only those patients with mutations at codon p.Met41 were included in the investigators’ analysis. Mutations at that site account for nearly all cases of VEXAS that have been identified to date.

The most common clinical manifestation of VEXAS was skin involvement, which occurred in all but one of the 83 patients. Other common manifestations included arthritis (58 patients), pulmonary infiltrates (57 patients), and ear chondritis (54 patients).



Fifteen patients were found to have the leucine variant, 18 had the valine variant, and 50 had the threonine variant. The median age at disease onset was 66 years in the leucine and threonine variant groups and 65 in the valine variant group.

The clinical diagnosis differed according to genotype: 4 of 18 patients (22%) with the valine variant were diagnosed with relapsing polychondritis, compared with 8 of 15 (53%) with the leucine variant and 31 of 50 (62%) with the threonine variant (P = .01).

In contrast, 55% of patients with valine genotype were diagnosed with undifferentiated fever, compared with 6% of those with the leucine and 16% with the threonine genotypes (P = .001). More patients with the leucine variant (60%) were diagnosed with Sweet syndrome, compared with 11% and 14% of patients with the valine and threonine variants, respectively (P = .001).

There was no significant difference among the three genotypes in the percentage of patients diagnosed with MDS.

The follow-up period ranged from 1 to 18 years (median, 4.7 years). The median survival time from disease onset for all patients was 10 years.

Among patients with the valine variant, median survival was 9 years, which was significantly less than among patients with the other two variants (P = .01).

In univariable analysis, independent predictors of mortality were ear chondritis (hazard ratio, 0.26; P = .005), transfusion dependence, a time-dependent variable (HR, 2.59; P = .03), and the valine variant (HR, 3.5; P = .008).

The association between VEXAS genotype and phenotype could be explained by the finding that, among patients with the valine variant, there was significantly less translation of the catalytically proficient UBA1b isoform than in patients with the other two variants, Dr. Ferrada said.

Therapeutic options

Dr. Ferrada noted that to date no drugs have been shown to provide consistent therapeutic benefits for patients with VEXAS, but evidence as to the etiology of the syndrome points to possible treatment approaches.

“All of these findings I think are extremely important to help us guide management of these patients, as we know that the mutation is located in the stem cells in the bone marrow. So we suspect that doing a bone marrow transplant in these patients is going to be curative,” Dr. Ferrada said during the briefing.

Investigators are planning a phase 2 trial of allogeneic hematopoietic stem cell transplant for patients with VEXAS.

The study was supported by the National Institutes of Health. Dr. Ferrada, Dr. Sandhu, and Dr. Kim have disclosed no relevant financial relationships.

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

Among patients with the recently defined severe autoinflammatory syndrome VEXAS, those who are transfusion dependent or have a specific amino acid substitution are at highest risk for death, whereas those with ear chondritis are at significantly lower risk, a multinational team of investigators has found.

Courtesy Dr. Marcela Ferrada
Auricular chondritis in a man with VEXAS

Their study of mortality and predictors of survival among patients with genetically confirmed VEXAS showed that patients with a VEXAS variant resulting in an amino acid substitution of a methionine for a valine had a 3.5-fold higher risk for death, compared with patients with either a methionine-to-threonine substitution or a methionine-to-leucine swap.

Transfusion dependence was an independent predictor of mortality. Patients who became dependent on transfusions after symptom onset had a nearly threefold higher risk for death, reported Marcela A. Ferrada, MD, a clinical fellow at the National Institute of Arthritis and Musculoskeletal and Skin Diseases.

“These findings should inform risk assessment and clinical management in patients with VEXAS syndrome,” she said in an oral abstract presentation during the virtual annual meeting of the American College of Rheumatology.

“These genetic findings have proven right now to be not only diagnostic, but we have shown that they’re also prognostic, and we hope that this is going to help us identify patients who could have more aggressive treatment,” Dr. Ferrada said.



She also discussed her findings in a media briefing held 2 days prior to her plenary presentation. At that briefing, this news organization asked participating clinicians whether they had patients who they suspected may have had undiagnosed VEXAS.

“My answer to that is interesting,” replied moderator Vaneet Sandhu, MD, from Loma Linda (Calif.) University and Riverside University Health System.

“In the last couple of days, I’ve been reading about VEXAS, and actually texted one of my colleagues yesterday and said, ‘Hey, you know these patients we’ve been seeing who have these strange rashes and chondritis and have maybe a diagnosis of leukocytoclastic vasculitis or something else – are we not diagnosing these patients?’ ” she said.

“I think we are looking at every patient with chondritis and reexamining their phenotype. We had dismissed certain symptoms because they didn’t fit the archetype for relapsing polychondritis, for example, but it could be VEXAS,” said Alfred Kim, MD, PhD, of Washington University in St. Louis, who also presented data during the briefing.

Three variants

VEXAS is caused by somatic mutations in UBA1, a gene that initiates cytoplasmic ubiquitylation, a process by which misfolded proteins are tagged for degradation.

The syndrome’s name is an acronym descriptive of the major features:

  • Vacuoles in bone marrow cells.
  • E-1 activating enzyme that UBA1 encodes for.
  • X-linked.
  • Autoinflammatory.
  • Somatic mutation featuring hematologic mosaicism.

VEXAS results in rheumatologic, dermatologic, and hematologic symptoms that are often misdiagnosed as being caused by treatment-refractory relapsing polychondritis, polyarteritis nodosa, Sweet syndrome, giant cell arteritis, or myelodysplastic syndrome (MDS).

VEXAS was identified as a distinct syndrome within the past year by Dr. Ferrada and other investigators at NIAMS, the National Human Genome Research Institute, and other institutions.

In the study reported at ACR 2021, Dr. Ferrada and colleagues assessed 83 men who had been referred for genetic testing for VEXAS at the National Institutes of Health, in Bethesda, Md., and at Leeds (England) Teaching Hospitals NHS Trust.

All patients were confirmed to have VEXAS-defining genetic mutations in UBA1 by Sanger sequencing of peripheral blood samples. Only those patients with mutations at codon p.Met41 were included in the investigators’ analysis. Mutations at that site account for nearly all cases of VEXAS that have been identified to date.

The most common clinical manifestation of VEXAS was skin involvement, which occurred in all but one of the 83 patients. Other common manifestations included arthritis (58 patients), pulmonary infiltrates (57 patients), and ear chondritis (54 patients).



Fifteen patients were found to have the leucine variant, 18 had the valine variant, and 50 had the threonine variant. The median age at disease onset was 66 years in the leucine and threonine variant groups and 65 in the valine variant group.

The clinical diagnosis differed according to genotype: 4 of 18 patients (22%) with the valine variant were diagnosed with relapsing polychondritis, compared with 8 of 15 (53%) with the leucine variant and 31 of 50 (62%) with the threonine variant (P = .01).

In contrast, 55% of patients with valine genotype were diagnosed with undifferentiated fever, compared with 6% of those with the leucine and 16% with the threonine genotypes (P = .001). More patients with the leucine variant (60%) were diagnosed with Sweet syndrome, compared with 11% and 14% of patients with the valine and threonine variants, respectively (P = .001).

There was no significant difference among the three genotypes in the percentage of patients diagnosed with MDS.

The follow-up period ranged from 1 to 18 years (median, 4.7 years). The median survival time from disease onset for all patients was 10 years.

Among patients with the valine variant, median survival was 9 years, which was significantly less than among patients with the other two variants (P = .01).

In univariable analysis, independent predictors of mortality were ear chondritis (hazard ratio, 0.26; P = .005), transfusion dependence, a time-dependent variable (HR, 2.59; P = .03), and the valine variant (HR, 3.5; P = .008).

The association between VEXAS genotype and phenotype could be explained by the finding that, among patients with the valine variant, there was significantly less translation of the catalytically proficient UBA1b isoform than in patients with the other two variants, Dr. Ferrada said.

Therapeutic options

Dr. Ferrada noted that to date no drugs have been shown to provide consistent therapeutic benefits for patients with VEXAS, but evidence as to the etiology of the syndrome points to possible treatment approaches.

“All of these findings I think are extremely important to help us guide management of these patients, as we know that the mutation is located in the stem cells in the bone marrow. So we suspect that doing a bone marrow transplant in these patients is going to be curative,” Dr. Ferrada said during the briefing.

Investigators are planning a phase 2 trial of allogeneic hematopoietic stem cell transplant for patients with VEXAS.

The study was supported by the National Institutes of Health. Dr. Ferrada, Dr. Sandhu, and Dr. Kim have disclosed no relevant financial relationships.

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

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