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Can a Mediterranean diet ease depression in young men?
This transcript has been edited for clarity.
Drew Ramsey, MD: Welcome back, everyone. I’m Dr. Drew Ramsey. I’m on the editorial board with Medscape Psychiatry and I’m an assistant clinical professor of psychiatry at Columbia University. We have a special guest today.
I’m here with nutritionist Jessica Bayes, who’s at the University of Technology Sydney, and she’s the lead author of the AMMEND trial. [Editor’s note: Since completing her PhD, Bayes is now at Southern Cross University.]
Jessica, welcome to Medscape.
Jessica Bayes, PhD: Thank you for having me.
The AMMEND Trial
Dr. Ramsey: Thank you for coming on board and helping all of us as clinicians understand some of your research and some of what is suggested by your research – that young men can change their diet and it helped their depression. Tell us a little bit about the AMMEND trial.
Dr. Bayes: The AMMEND trial was a 12-week randomized controlled trial in young men, 18-25 years old, who had diagnosed moderate to severe clinical depression. They had a poor baseline diet and we got them to eat a healthy Mediterranean diet, which improved their symptoms of depression.
Dr. Ramsey: It was a remarkable trial. Jessica, if I recall, you helped individuals improve the Mediterranean dietary pattern score by 8 points on a 14-point scale. That led to a 20-point reduction in their Beck Depression Inventory. Tell us what that looked like on the ground.
Dr. Bayes: It’s a huge improvement. Obviously, they were feeling much better in the end in terms of their depressive symptoms, but we also measured their energy, sleep, and quality of life. Many of them at the end were at a score cutoff that suggests no depression or in remission.
Dr. Ramsey: There were 72 people in your total trial, so 36% in your intervention arm went into full remission.
Dr. Bayes: Which is just amazing.
Dr. Ramsey: It also follows up the SMILES trial, which was a little bit of a different trial. You had two nutritional counseling sessions and the SMILES trial had seven, but in the SMILES trial, 32.3% of the patients went into full remission when they adopted a Mediterranean-style diet.
Jessica, what is the secret that you and your team know? I think many clinicians, especially clinicians who are parents and have teens, are kind of shaking their heads in disbelief. They’ve been telling their kids to eat healthy. What do you guys know about how to help young men change their diet?
How to Aid Adherence to Mediterranean Diet
Dr. Bayes: Prior to starting this, when I would say this idea to people, everyone would say, “Great idea. There’s no way you’re going to get depressed young men to change their diet. Not going to happen.” We went to them and we asked them. We said, “We’re going to do this study. What do you want from us? What resources would you need? How many appointments would you like? What’s too little or too many?”
We really got their feedback on board when we designed the study, and that obviously paid off. We had a personalized approach and we met them where they were at. We gave them the skills, resources, recipes, meal ideas – all those things – so we could really set them up to succeed.
Dr. Ramsey: You were telling me earlier about a few of the dietary changes that you felt made a big difference for these young men. What were those?
Dr. Bayes: Increasing the vegetables, olive oil, and legumes are probably the big ones that most of them were really not doing beforehand. They were really able to take that on board and make significant improvements in those areas.
Dr. Ramsey: These are really some of the top food categories in nutritional psychiatry as we think about how we help our efforts to improve mental health by thinking about nutrition, nutritional quality, and nutritional density. Certainly, those food categories – nuts and legumes, plants, and olive oil – are really what help get us there.
You also gave the students a food hamper. If you were going to be in charge of mental health in Australia and America and you got to give every college freshman a little box with a note, what would be in that box?
Dr. Bayes: I’d want to put everything in that box! It would be full of brightly colored fruits and vegetables, different nuts and seeds, and legumes. It would be full of recipes and ideas of how to cook things and how to prepare really delicious things. It would be full of different herbs and spices and all of those things to get people really excited about food.
Dr. Ramsey: Did the young men pick up on your enthusiasm and excitement around food? Did they begin to adopt some of that, shifting their view of how they saw the food and how they saw that it is related to their depression?
Dr. Bayes: Hopefully. I do think energy is infectious. I’m sure that played a role somewhat, but trying to get them excited about food can be really quite daunting, thinking, I’ve got to change my entire diet and I’ve got to learn to cook and go out and buy groceries. I don’t even know what to do with a piece of salmon. Trying to get them curious, interested, and just reminding them that it’s not all-or-nothing. Make small changes, give it a go, and have fun.
Dr. Ramsey: You also have a unique aspect of your research that you’re interested in male mental health, and that’s not something that’s been widely researched. Can you tell us a little bit about what these men were like in terms of coming into your trial as depressed young men?
Dr. Bayes: In the context of the COVID-19 pandemic, mental health was at the forefront of many people’s minds. They joined the study saying, “I’ve never seen anything like this before. I’ve never seen myself represented in research. I wanted to contribute. I want to add to that conversation because I feel like we are overlooked.”
Dr. Ramsey: I love hearing this notion that maybe young men aren’t quite who we think they are. They are wanting to be seen around their mental health. They can learn to use olive oil and to cook, and they can engage in mental health interventions that work. We just need to ask, give them some food, encourage them, and it makes a big difference.
Jessica Bayes, thank you so much for joining us and sharing some of your research. Everyone, it’s the AMMEND trial. We will drop a link to the trial below so you can take a peek and tell us what you think.
Please, in the comments, let us know what you think about this notion of helping young men with depression through nutritional interventions. Take a peek at the great work that Jessica and Professor Sibbritt from the University of Technology Sydney have published and put out into the scientific literature for us all.
Thanks so much, Jessica. I look forward to seeing you soon.
Dr. Bayes: Thank you.
Dr. Ramsey is assistant clinical professor, department of psychiatry, Columbia University, New York. He has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for InterContinental Hotels Group; National Kale Day 501(c)3. Received income in an amount equal to or greater than $250 from: Sharecare. Dr. Bayes is a postdoctoral research fellow; clinical nutritionist, Southern Cross University, National Center for Naturopathic Medicine, Lismore, New South Wales, Australia. She has disclosed the following relevant financial relationships: Received research grant from Endeavour College. A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Drew Ramsey, MD: Welcome back, everyone. I’m Dr. Drew Ramsey. I’m on the editorial board with Medscape Psychiatry and I’m an assistant clinical professor of psychiatry at Columbia University. We have a special guest today.
I’m here with nutritionist Jessica Bayes, who’s at the University of Technology Sydney, and she’s the lead author of the AMMEND trial. [Editor’s note: Since completing her PhD, Bayes is now at Southern Cross University.]
Jessica, welcome to Medscape.
Jessica Bayes, PhD: Thank you for having me.
The AMMEND Trial
Dr. Ramsey: Thank you for coming on board and helping all of us as clinicians understand some of your research and some of what is suggested by your research – that young men can change their diet and it helped their depression. Tell us a little bit about the AMMEND trial.
Dr. Bayes: The AMMEND trial was a 12-week randomized controlled trial in young men, 18-25 years old, who had diagnosed moderate to severe clinical depression. They had a poor baseline diet and we got them to eat a healthy Mediterranean diet, which improved their symptoms of depression.
Dr. Ramsey: It was a remarkable trial. Jessica, if I recall, you helped individuals improve the Mediterranean dietary pattern score by 8 points on a 14-point scale. That led to a 20-point reduction in their Beck Depression Inventory. Tell us what that looked like on the ground.
Dr. Bayes: It’s a huge improvement. Obviously, they were feeling much better in the end in terms of their depressive symptoms, but we also measured their energy, sleep, and quality of life. Many of them at the end were at a score cutoff that suggests no depression or in remission.
Dr. Ramsey: There were 72 people in your total trial, so 36% in your intervention arm went into full remission.
Dr. Bayes: Which is just amazing.
Dr. Ramsey: It also follows up the SMILES trial, which was a little bit of a different trial. You had two nutritional counseling sessions and the SMILES trial had seven, but in the SMILES trial, 32.3% of the patients went into full remission when they adopted a Mediterranean-style diet.
Jessica, what is the secret that you and your team know? I think many clinicians, especially clinicians who are parents and have teens, are kind of shaking their heads in disbelief. They’ve been telling their kids to eat healthy. What do you guys know about how to help young men change their diet?
How to Aid Adherence to Mediterranean Diet
Dr. Bayes: Prior to starting this, when I would say this idea to people, everyone would say, “Great idea. There’s no way you’re going to get depressed young men to change their diet. Not going to happen.” We went to them and we asked them. We said, “We’re going to do this study. What do you want from us? What resources would you need? How many appointments would you like? What’s too little or too many?”
We really got their feedback on board when we designed the study, and that obviously paid off. We had a personalized approach and we met them where they were at. We gave them the skills, resources, recipes, meal ideas – all those things – so we could really set them up to succeed.
Dr. Ramsey: You were telling me earlier about a few of the dietary changes that you felt made a big difference for these young men. What were those?
Dr. Bayes: Increasing the vegetables, olive oil, and legumes are probably the big ones that most of them were really not doing beforehand. They were really able to take that on board and make significant improvements in those areas.
Dr. Ramsey: These are really some of the top food categories in nutritional psychiatry as we think about how we help our efforts to improve mental health by thinking about nutrition, nutritional quality, and nutritional density. Certainly, those food categories – nuts and legumes, plants, and olive oil – are really what help get us there.
You also gave the students a food hamper. If you were going to be in charge of mental health in Australia and America and you got to give every college freshman a little box with a note, what would be in that box?
Dr. Bayes: I’d want to put everything in that box! It would be full of brightly colored fruits and vegetables, different nuts and seeds, and legumes. It would be full of recipes and ideas of how to cook things and how to prepare really delicious things. It would be full of different herbs and spices and all of those things to get people really excited about food.
Dr. Ramsey: Did the young men pick up on your enthusiasm and excitement around food? Did they begin to adopt some of that, shifting their view of how they saw the food and how they saw that it is related to their depression?
Dr. Bayes: Hopefully. I do think energy is infectious. I’m sure that played a role somewhat, but trying to get them excited about food can be really quite daunting, thinking, I’ve got to change my entire diet and I’ve got to learn to cook and go out and buy groceries. I don’t even know what to do with a piece of salmon. Trying to get them curious, interested, and just reminding them that it’s not all-or-nothing. Make small changes, give it a go, and have fun.
Dr. Ramsey: You also have a unique aspect of your research that you’re interested in male mental health, and that’s not something that’s been widely researched. Can you tell us a little bit about what these men were like in terms of coming into your trial as depressed young men?
Dr. Bayes: In the context of the COVID-19 pandemic, mental health was at the forefront of many people’s minds. They joined the study saying, “I’ve never seen anything like this before. I’ve never seen myself represented in research. I wanted to contribute. I want to add to that conversation because I feel like we are overlooked.”
Dr. Ramsey: I love hearing this notion that maybe young men aren’t quite who we think they are. They are wanting to be seen around their mental health. They can learn to use olive oil and to cook, and they can engage in mental health interventions that work. We just need to ask, give them some food, encourage them, and it makes a big difference.
Jessica Bayes, thank you so much for joining us and sharing some of your research. Everyone, it’s the AMMEND trial. We will drop a link to the trial below so you can take a peek and tell us what you think.
Please, in the comments, let us know what you think about this notion of helping young men with depression through nutritional interventions. Take a peek at the great work that Jessica and Professor Sibbritt from the University of Technology Sydney have published and put out into the scientific literature for us all.
Thanks so much, Jessica. I look forward to seeing you soon.
Dr. Bayes: Thank you.
Dr. Ramsey is assistant clinical professor, department of psychiatry, Columbia University, New York. He has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for InterContinental Hotels Group; National Kale Day 501(c)3. Received income in an amount equal to or greater than $250 from: Sharecare. Dr. Bayes is a postdoctoral research fellow; clinical nutritionist, Southern Cross University, National Center for Naturopathic Medicine, Lismore, New South Wales, Australia. She has disclosed the following relevant financial relationships: Received research grant from Endeavour College. A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Drew Ramsey, MD: Welcome back, everyone. I’m Dr. Drew Ramsey. I’m on the editorial board with Medscape Psychiatry and I’m an assistant clinical professor of psychiatry at Columbia University. We have a special guest today.
I’m here with nutritionist Jessica Bayes, who’s at the University of Technology Sydney, and she’s the lead author of the AMMEND trial. [Editor’s note: Since completing her PhD, Bayes is now at Southern Cross University.]
Jessica, welcome to Medscape.
Jessica Bayes, PhD: Thank you for having me.
The AMMEND Trial
Dr. Ramsey: Thank you for coming on board and helping all of us as clinicians understand some of your research and some of what is suggested by your research – that young men can change their diet and it helped their depression. Tell us a little bit about the AMMEND trial.
Dr. Bayes: The AMMEND trial was a 12-week randomized controlled trial in young men, 18-25 years old, who had diagnosed moderate to severe clinical depression. They had a poor baseline diet and we got them to eat a healthy Mediterranean diet, which improved their symptoms of depression.
Dr. Ramsey: It was a remarkable trial. Jessica, if I recall, you helped individuals improve the Mediterranean dietary pattern score by 8 points on a 14-point scale. That led to a 20-point reduction in their Beck Depression Inventory. Tell us what that looked like on the ground.
Dr. Bayes: It’s a huge improvement. Obviously, they were feeling much better in the end in terms of their depressive symptoms, but we also measured their energy, sleep, and quality of life. Many of them at the end were at a score cutoff that suggests no depression or in remission.
Dr. Ramsey: There were 72 people in your total trial, so 36% in your intervention arm went into full remission.
Dr. Bayes: Which is just amazing.
Dr. Ramsey: It also follows up the SMILES trial, which was a little bit of a different trial. You had two nutritional counseling sessions and the SMILES trial had seven, but in the SMILES trial, 32.3% of the patients went into full remission when they adopted a Mediterranean-style diet.
Jessica, what is the secret that you and your team know? I think many clinicians, especially clinicians who are parents and have teens, are kind of shaking their heads in disbelief. They’ve been telling their kids to eat healthy. What do you guys know about how to help young men change their diet?
How to Aid Adherence to Mediterranean Diet
Dr. Bayes: Prior to starting this, when I would say this idea to people, everyone would say, “Great idea. There’s no way you’re going to get depressed young men to change their diet. Not going to happen.” We went to them and we asked them. We said, “We’re going to do this study. What do you want from us? What resources would you need? How many appointments would you like? What’s too little or too many?”
We really got their feedback on board when we designed the study, and that obviously paid off. We had a personalized approach and we met them where they were at. We gave them the skills, resources, recipes, meal ideas – all those things – so we could really set them up to succeed.
Dr. Ramsey: You were telling me earlier about a few of the dietary changes that you felt made a big difference for these young men. What were those?
Dr. Bayes: Increasing the vegetables, olive oil, and legumes are probably the big ones that most of them were really not doing beforehand. They were really able to take that on board and make significant improvements in those areas.
Dr. Ramsey: These are really some of the top food categories in nutritional psychiatry as we think about how we help our efforts to improve mental health by thinking about nutrition, nutritional quality, and nutritional density. Certainly, those food categories – nuts and legumes, plants, and olive oil – are really what help get us there.
You also gave the students a food hamper. If you were going to be in charge of mental health in Australia and America and you got to give every college freshman a little box with a note, what would be in that box?
Dr. Bayes: I’d want to put everything in that box! It would be full of brightly colored fruits and vegetables, different nuts and seeds, and legumes. It would be full of recipes and ideas of how to cook things and how to prepare really delicious things. It would be full of different herbs and spices and all of those things to get people really excited about food.
Dr. Ramsey: Did the young men pick up on your enthusiasm and excitement around food? Did they begin to adopt some of that, shifting their view of how they saw the food and how they saw that it is related to their depression?
Dr. Bayes: Hopefully. I do think energy is infectious. I’m sure that played a role somewhat, but trying to get them excited about food can be really quite daunting, thinking, I’ve got to change my entire diet and I’ve got to learn to cook and go out and buy groceries. I don’t even know what to do with a piece of salmon. Trying to get them curious, interested, and just reminding them that it’s not all-or-nothing. Make small changes, give it a go, and have fun.
Dr. Ramsey: You also have a unique aspect of your research that you’re interested in male mental health, and that’s not something that’s been widely researched. Can you tell us a little bit about what these men were like in terms of coming into your trial as depressed young men?
Dr. Bayes: In the context of the COVID-19 pandemic, mental health was at the forefront of many people’s minds. They joined the study saying, “I’ve never seen anything like this before. I’ve never seen myself represented in research. I wanted to contribute. I want to add to that conversation because I feel like we are overlooked.”
Dr. Ramsey: I love hearing this notion that maybe young men aren’t quite who we think they are. They are wanting to be seen around their mental health. They can learn to use olive oil and to cook, and they can engage in mental health interventions that work. We just need to ask, give them some food, encourage them, and it makes a big difference.
Jessica Bayes, thank you so much for joining us and sharing some of your research. Everyone, it’s the AMMEND trial. We will drop a link to the trial below so you can take a peek and tell us what you think.
Please, in the comments, let us know what you think about this notion of helping young men with depression through nutritional interventions. Take a peek at the great work that Jessica and Professor Sibbritt from the University of Technology Sydney have published and put out into the scientific literature for us all.
Thanks so much, Jessica. I look forward to seeing you soon.
Dr. Bayes: Thank you.
Dr. Ramsey is assistant clinical professor, department of psychiatry, Columbia University, New York. He has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for InterContinental Hotels Group; National Kale Day 501(c)3. Received income in an amount equal to or greater than $250 from: Sharecare. Dr. Bayes is a postdoctoral research fellow; clinical nutritionist, Southern Cross University, National Center for Naturopathic Medicine, Lismore, New South Wales, Australia. She has disclosed the following relevant financial relationships: Received research grant from Endeavour College. A version of this article first appeared on Medscape.com.
Getting testosterone online is easy. Solid advice, not so much
When a secret shopper used telemedicine to request testosterone supplements, options were plentiful but good advice was scarce. As researchers showed, companies offered testosterone replacement therapy to the prospective buyer even though his stated T level was much higher than the cut-off for low testosterone levels.
Direct-to-consumer (DTC) delivery of testosterone or medications for erectile dysfunction has become routine. The many benefits of wide access include convenience and the ability to discuss sensitive topics in a safe environment. But as the new findings indicate, a lack of adherence to solid medical advice – such as guidance from the Endocrine Society and the American Urological Association – may be putting some people at risk for potentially harmful outcomes.
The Endocrine Society and the AUA state that only people with true testosterone deficiency should receive a T boost. Both groups discourage men who are planning to become parents in the near future from taking supplemental testosterone because of possible harms to their fertility.
“When guidelines are not being followed, there’s always the potential that we might not get the best outcomes for patients,” said Joshua A. Halpern, MD, a urologist at the Northwestern University Feinberg School of Medicine, Chicago, who led the study, which was published in JAMA Internal Medicine.
To conduct the research, the secret shopper approached seven different DTC testosterone websites with the same story for each: He was a 34-year-old man with low energy and libido who hoped to become a father soon. The customer noted that he had a testosterone level of 675 ng/dL, well above the 300 ng/dL the AUA considers low.
Despite these red flags – the normal T levels, the parenthood aspirations – representatives of almost every platform moved the shopper along toward receiving additional testosterone, with no attention to the possible harms to fertility. Only one platform declined to offer the testosterone because the shopper’s T levels were sufficient. In the other cases the secret shopper did not go forward with obtaining the medication, which would have required a prescription.
“Our goal with this study was to achieve a better understanding of what patients are experiencing and what’s out there,” Dr. Halpern said. While this study focused on cisgender patients, Dr. Halpern noted that it’s also important to understand the experiences of transgender patients who seek DTC hormonal therapy.
The research could help keep DTC companies more honest, according to Jesse N. Mills, MD, a urologist and men’s health specialist at the University of California, Los Angeles, who was not involved in the work. DTC platforms are financially incentivized to dispense medications regardless of need, unlike a traditional doctor who generally has no personal financial stake in a prescription.
“We need to keep the heat on DTC platforms,” Dr. Mills said, calling the article a “punchback” against the current DTC model for testosterone products. Dr. Mills said he is not opposed to telemedicine or DTC practices in general, adding that UCLA made a successful pivot to telemedicine during the pandemic.
“You can set up a lot of good care through video visits,” Dr. Mills said, as long as the system is ethical.
Dr. Halpern and Dr. Mills reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
When a secret shopper used telemedicine to request testosterone supplements, options were plentiful but good advice was scarce. As researchers showed, companies offered testosterone replacement therapy to the prospective buyer even though his stated T level was much higher than the cut-off for low testosterone levels.
Direct-to-consumer (DTC) delivery of testosterone or medications for erectile dysfunction has become routine. The many benefits of wide access include convenience and the ability to discuss sensitive topics in a safe environment. But as the new findings indicate, a lack of adherence to solid medical advice – such as guidance from the Endocrine Society and the American Urological Association – may be putting some people at risk for potentially harmful outcomes.
The Endocrine Society and the AUA state that only people with true testosterone deficiency should receive a T boost. Both groups discourage men who are planning to become parents in the near future from taking supplemental testosterone because of possible harms to their fertility.
“When guidelines are not being followed, there’s always the potential that we might not get the best outcomes for patients,” said Joshua A. Halpern, MD, a urologist at the Northwestern University Feinberg School of Medicine, Chicago, who led the study, which was published in JAMA Internal Medicine.
To conduct the research, the secret shopper approached seven different DTC testosterone websites with the same story for each: He was a 34-year-old man with low energy and libido who hoped to become a father soon. The customer noted that he had a testosterone level of 675 ng/dL, well above the 300 ng/dL the AUA considers low.
Despite these red flags – the normal T levels, the parenthood aspirations – representatives of almost every platform moved the shopper along toward receiving additional testosterone, with no attention to the possible harms to fertility. Only one platform declined to offer the testosterone because the shopper’s T levels were sufficient. In the other cases the secret shopper did not go forward with obtaining the medication, which would have required a prescription.
“Our goal with this study was to achieve a better understanding of what patients are experiencing and what’s out there,” Dr. Halpern said. While this study focused on cisgender patients, Dr. Halpern noted that it’s also important to understand the experiences of transgender patients who seek DTC hormonal therapy.
The research could help keep DTC companies more honest, according to Jesse N. Mills, MD, a urologist and men’s health specialist at the University of California, Los Angeles, who was not involved in the work. DTC platforms are financially incentivized to dispense medications regardless of need, unlike a traditional doctor who generally has no personal financial stake in a prescription.
“We need to keep the heat on DTC platforms,” Dr. Mills said, calling the article a “punchback” against the current DTC model for testosterone products. Dr. Mills said he is not opposed to telemedicine or DTC practices in general, adding that UCLA made a successful pivot to telemedicine during the pandemic.
“You can set up a lot of good care through video visits,” Dr. Mills said, as long as the system is ethical.
Dr. Halpern and Dr. Mills reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
When a secret shopper used telemedicine to request testosterone supplements, options were plentiful but good advice was scarce. As researchers showed, companies offered testosterone replacement therapy to the prospective buyer even though his stated T level was much higher than the cut-off for low testosterone levels.
Direct-to-consumer (DTC) delivery of testosterone or medications for erectile dysfunction has become routine. The many benefits of wide access include convenience and the ability to discuss sensitive topics in a safe environment. But as the new findings indicate, a lack of adherence to solid medical advice – such as guidance from the Endocrine Society and the American Urological Association – may be putting some people at risk for potentially harmful outcomes.
The Endocrine Society and the AUA state that only people with true testosterone deficiency should receive a T boost. Both groups discourage men who are planning to become parents in the near future from taking supplemental testosterone because of possible harms to their fertility.
“When guidelines are not being followed, there’s always the potential that we might not get the best outcomes for patients,” said Joshua A. Halpern, MD, a urologist at the Northwestern University Feinberg School of Medicine, Chicago, who led the study, which was published in JAMA Internal Medicine.
To conduct the research, the secret shopper approached seven different DTC testosterone websites with the same story for each: He was a 34-year-old man with low energy and libido who hoped to become a father soon. The customer noted that he had a testosterone level of 675 ng/dL, well above the 300 ng/dL the AUA considers low.
Despite these red flags – the normal T levels, the parenthood aspirations – representatives of almost every platform moved the shopper along toward receiving additional testosterone, with no attention to the possible harms to fertility. Only one platform declined to offer the testosterone because the shopper’s T levels were sufficient. In the other cases the secret shopper did not go forward with obtaining the medication, which would have required a prescription.
“Our goal with this study was to achieve a better understanding of what patients are experiencing and what’s out there,” Dr. Halpern said. While this study focused on cisgender patients, Dr. Halpern noted that it’s also important to understand the experiences of transgender patients who seek DTC hormonal therapy.
The research could help keep DTC companies more honest, according to Jesse N. Mills, MD, a urologist and men’s health specialist at the University of California, Los Angeles, who was not involved in the work. DTC platforms are financially incentivized to dispense medications regardless of need, unlike a traditional doctor who generally has no personal financial stake in a prescription.
“We need to keep the heat on DTC platforms,” Dr. Mills said, calling the article a “punchback” against the current DTC model for testosterone products. Dr. Mills said he is not opposed to telemedicine or DTC practices in general, adding that UCLA made a successful pivot to telemedicine during the pandemic.
“You can set up a lot of good care through video visits,” Dr. Mills said, as long as the system is ethical.
Dr. Halpern and Dr. Mills reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Have you heard of VEXAS syndrome?
Its name is an acronym: Vacuoles, E1 enzyme, X-linked, Autoinflammatory, Somatic. The prevalence of this syndrome is unknown, but it is not so rare. As it is an X-linked disease, men are predominantly affected.
First identification
The NIH team screened the exomes and genomes of 2,560 individuals. Of this group, 1,477 had been referred because of undiagnosed recurrent fevers, systemic inflammation, or both, and 1,083 were affected by atypical, unclassified disorders. The researchers identified 25 men with a somatic mutation in the ubiquitin-like modifier activating enzyme 1 (UBA1) gene, which is involved in the protein ubiquitylation system. This posttranslational modification has a pleiotropic function that likely explains the clinical heterogeneity seen in VEXAS patients: regulation of protein turnover, especially those involved in the cell cycle, cell death, and signal transduction. Ubiquitylation is also involved in nonproteolytic functions, such as assembly of multiprotein complexes, intracellular signaling, inflammatory signaling, and DNA repair.
Clinical presentation
The clinicobiological presentation of VEXAS syndrome is very heterogeneous. Typically, patients present with a systemic inflammatory disease with unexplained episodes of fever, involvement of the lungs, skin, blood vessels, and joints. Molecular diagnosis is made by the sequencing of UBA1.
Most patients present with the characteristic clinical signs of other inflammatory diseases, such as polyarteritis nodosa and recurrent polychondritis. But VEXAS patients are at high risk of developing hematologic conditions. Indeed, the following were seen among the 25 participants in the NIH study: macrocytic anemia (96%), venous thromboembolism (44%), myelodysplastic syndrome (24%), and multiple myeloma or monoclonal gammopathy of undetermined significance (20%).
In VEXAS patients, levels of serum inflammatory markers are increased. These markers include tumor necrosis factor, interleukin-8, interleukin-6, interferon-inducible protein-10, interferon-gamma, C-reactive protein. In addition, there is aberrant activation of innate immune-signaling pathways.
In a large-scale analysis of a multicenter case series of 116 French patients, researchers found that VEXAS syndrome primarily affected men. The disease was progressive, and onset occurred after age 50 years. These patients can be divided into three phenotypically distinct clusters on the basis of integration of clinical and biological data. In the 58 cases in which myelodysplastic syndrome was present, the mortality rates were higher. The researchers also reported that the UBA1 p.Met41L mutation was associated with a better prognosis.
Treatment data
VEXAS syndrome resists the classical therapeutic arsenal. Patients require high-dose glucocorticoids, and prognosis appears to be poor. The available treatment data are retrospective. Of the 25 participants in the NIH study, 40% died within 5 years from disease-related causes or complications related to treatment. Among the promising therapeutic avenues is the use of inhibitors of the Janus kinase pathway.
This article was translated from Univadis France. A version of this article appeared on Medscape.com.
Its name is an acronym: Vacuoles, E1 enzyme, X-linked, Autoinflammatory, Somatic. The prevalence of this syndrome is unknown, but it is not so rare. As it is an X-linked disease, men are predominantly affected.
First identification
The NIH team screened the exomes and genomes of 2,560 individuals. Of this group, 1,477 had been referred because of undiagnosed recurrent fevers, systemic inflammation, or both, and 1,083 were affected by atypical, unclassified disorders. The researchers identified 25 men with a somatic mutation in the ubiquitin-like modifier activating enzyme 1 (UBA1) gene, which is involved in the protein ubiquitylation system. This posttranslational modification has a pleiotropic function that likely explains the clinical heterogeneity seen in VEXAS patients: regulation of protein turnover, especially those involved in the cell cycle, cell death, and signal transduction. Ubiquitylation is also involved in nonproteolytic functions, such as assembly of multiprotein complexes, intracellular signaling, inflammatory signaling, and DNA repair.
Clinical presentation
The clinicobiological presentation of VEXAS syndrome is very heterogeneous. Typically, patients present with a systemic inflammatory disease with unexplained episodes of fever, involvement of the lungs, skin, blood vessels, and joints. Molecular diagnosis is made by the sequencing of UBA1.
Most patients present with the characteristic clinical signs of other inflammatory diseases, such as polyarteritis nodosa and recurrent polychondritis. But VEXAS patients are at high risk of developing hematologic conditions. Indeed, the following were seen among the 25 participants in the NIH study: macrocytic anemia (96%), venous thromboembolism (44%), myelodysplastic syndrome (24%), and multiple myeloma or monoclonal gammopathy of undetermined significance (20%).
In VEXAS patients, levels of serum inflammatory markers are increased. These markers include tumor necrosis factor, interleukin-8, interleukin-6, interferon-inducible protein-10, interferon-gamma, C-reactive protein. In addition, there is aberrant activation of innate immune-signaling pathways.
In a large-scale analysis of a multicenter case series of 116 French patients, researchers found that VEXAS syndrome primarily affected men. The disease was progressive, and onset occurred after age 50 years. These patients can be divided into three phenotypically distinct clusters on the basis of integration of clinical and biological data. In the 58 cases in which myelodysplastic syndrome was present, the mortality rates were higher. The researchers also reported that the UBA1 p.Met41L mutation was associated with a better prognosis.
Treatment data
VEXAS syndrome resists the classical therapeutic arsenal. Patients require high-dose glucocorticoids, and prognosis appears to be poor. The available treatment data are retrospective. Of the 25 participants in the NIH study, 40% died within 5 years from disease-related causes or complications related to treatment. Among the promising therapeutic avenues is the use of inhibitors of the Janus kinase pathway.
This article was translated from Univadis France. A version of this article appeared on Medscape.com.
Its name is an acronym: Vacuoles, E1 enzyme, X-linked, Autoinflammatory, Somatic. The prevalence of this syndrome is unknown, but it is not so rare. As it is an X-linked disease, men are predominantly affected.
First identification
The NIH team screened the exomes and genomes of 2,560 individuals. Of this group, 1,477 had been referred because of undiagnosed recurrent fevers, systemic inflammation, or both, and 1,083 were affected by atypical, unclassified disorders. The researchers identified 25 men with a somatic mutation in the ubiquitin-like modifier activating enzyme 1 (UBA1) gene, which is involved in the protein ubiquitylation system. This posttranslational modification has a pleiotropic function that likely explains the clinical heterogeneity seen in VEXAS patients: regulation of protein turnover, especially those involved in the cell cycle, cell death, and signal transduction. Ubiquitylation is also involved in nonproteolytic functions, such as assembly of multiprotein complexes, intracellular signaling, inflammatory signaling, and DNA repair.
Clinical presentation
The clinicobiological presentation of VEXAS syndrome is very heterogeneous. Typically, patients present with a systemic inflammatory disease with unexplained episodes of fever, involvement of the lungs, skin, blood vessels, and joints. Molecular diagnosis is made by the sequencing of UBA1.
Most patients present with the characteristic clinical signs of other inflammatory diseases, such as polyarteritis nodosa and recurrent polychondritis. But VEXAS patients are at high risk of developing hematologic conditions. Indeed, the following were seen among the 25 participants in the NIH study: macrocytic anemia (96%), venous thromboembolism (44%), myelodysplastic syndrome (24%), and multiple myeloma or monoclonal gammopathy of undetermined significance (20%).
In VEXAS patients, levels of serum inflammatory markers are increased. These markers include tumor necrosis factor, interleukin-8, interleukin-6, interferon-inducible protein-10, interferon-gamma, C-reactive protein. In addition, there is aberrant activation of innate immune-signaling pathways.
In a large-scale analysis of a multicenter case series of 116 French patients, researchers found that VEXAS syndrome primarily affected men. The disease was progressive, and onset occurred after age 50 years. These patients can be divided into three phenotypically distinct clusters on the basis of integration of clinical and biological data. In the 58 cases in which myelodysplastic syndrome was present, the mortality rates were higher. The researchers also reported that the UBA1 p.Met41L mutation was associated with a better prognosis.
Treatment data
VEXAS syndrome resists the classical therapeutic arsenal. Patients require high-dose glucocorticoids, and prognosis appears to be poor. The available treatment data are retrospective. Of the 25 participants in the NIH study, 40% died within 5 years from disease-related causes or complications related to treatment. Among the promising therapeutic avenues is the use of inhibitors of the Janus kinase pathway.
This article was translated from Univadis France. A version of this article appeared on Medscape.com.
Not all plant-based diets equal for CRC risk reduction
although the strength of the association may vary by race and ethnicity and tumor site, new research shows.
The “take-home message is that improving the quality of plant foods and reducing animal food consumption can help prevent colorectal cancer in men,” Jihye Kim told this news organization.
The findings suggest that “not all plant-based diets are the same with regard to colorectal cancer protection/risk,” said Ms. Kim, a professor in the College of Life and Sciences at Kyung Hee University in South Korea.
The study was published online in BMC Medicine.
The researchers investigated the risk for CRC in association with three plant-based dietary patterns defined by a priori indices: an overall plant-based diet index (PDI), a healthful plant-based diet index (hPDI), and an unhealthful plant-based diet index (uPDI).
All three indices negatively weigh animal foods but weigh plant foods differently depending on their nutritional quality.
Examples of foods contained in the hPDI include whole grains, fruits, vegetables, vegetable oils, nuts, legumes, tea, and coffee. Foods in the uPDI include refined grains, fruit juices, potatoes, and added sugars.
They calculated the PDI, hPDI, and uPDI using data from quantitative food frequency questionnaires provided by 79,952 men (mean age, 60 years at baseline) and 93,475 women (mean age, 59 years at baseline) in the Multiethnic Cohort Study.
During a mean follow-up of about 19 years, 4,976 participants developed CRC.
The plant-based diet indices were significantly inversely associated with the risk for CRC in men.
Researchers found that men with the greatest adherence to PDI and hPDI had a 24% (hazard ratio, 0.76) and 21% (HR, 0.79) lower risk for CRC, respectively, compared with men with the lowest adherence. No significant association was found between the risk for CRC in men and uPDI.
None of the plant-based diet indices was significantly associated with the risk for CRC in women, which could be because of different dietary habits between men and women, the researchers say.
In general, women consume more plant foods and less animal foods than men do, they point out.
In addition, women in the Multiethnic Cohort Study consumed higher amounts of healthy plant foods and lower amounts of less healthy plant foods compared with men, so they may not have further benefits with high scores of plant-based diet indices. Also, men are at higher risk for CRC than women are in general.
These findings suggest that the benefits from plant-based diets may vary by sex, race, and ethnicity, and anatomic subsite of tumor.
In men, the inverse association of overall PDI was greater in Japanese American, Native Hawaiian, and White groups than in African American and Latino groups, and for left colon and rectum tumors than for right colon tumors. The decreased risk with the hPDI was suggested across racial and ethnic groups and was observed for all tumor subsites.
“It was interesting to see that the association of a plant-based diet with CRC varied by race and ethnicity. It is not clear why. It could be nondietary lifestyle factors or genetic factors,” Ms. Kim told this news organization.
“We should investigate that more in the future,” Ms. Kim added.
By way of limitations, it’s possible that residual or unmeasured confounding might exist despite adjustment for key CRC risk factors, the researchers say. However, the subgroup analyses suggest that the impact of residual confounding due to body mass index, smoking status, and alcohol consumption was “minimal,” they note.
Another limitation is that the analysis was based on diet measured only at baseline, but dietary habits might change over time.
Overall, the findings “support that improving the quality of plant foods and reducing animal food consumption can help prevent colorectal cancer,” Ms. Kim and colleagues say.
The study was supported by the National Research Foundation of Korea and the U.S. National Cancer Institute and National Institutes of Health. The authors have declared no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
although the strength of the association may vary by race and ethnicity and tumor site, new research shows.
The “take-home message is that improving the quality of plant foods and reducing animal food consumption can help prevent colorectal cancer in men,” Jihye Kim told this news organization.
The findings suggest that “not all plant-based diets are the same with regard to colorectal cancer protection/risk,” said Ms. Kim, a professor in the College of Life and Sciences at Kyung Hee University in South Korea.
The study was published online in BMC Medicine.
The researchers investigated the risk for CRC in association with three plant-based dietary patterns defined by a priori indices: an overall plant-based diet index (PDI), a healthful plant-based diet index (hPDI), and an unhealthful plant-based diet index (uPDI).
All three indices negatively weigh animal foods but weigh plant foods differently depending on their nutritional quality.
Examples of foods contained in the hPDI include whole grains, fruits, vegetables, vegetable oils, nuts, legumes, tea, and coffee. Foods in the uPDI include refined grains, fruit juices, potatoes, and added sugars.
They calculated the PDI, hPDI, and uPDI using data from quantitative food frequency questionnaires provided by 79,952 men (mean age, 60 years at baseline) and 93,475 women (mean age, 59 years at baseline) in the Multiethnic Cohort Study.
During a mean follow-up of about 19 years, 4,976 participants developed CRC.
The plant-based diet indices were significantly inversely associated with the risk for CRC in men.
Researchers found that men with the greatest adherence to PDI and hPDI had a 24% (hazard ratio, 0.76) and 21% (HR, 0.79) lower risk for CRC, respectively, compared with men with the lowest adherence. No significant association was found between the risk for CRC in men and uPDI.
None of the plant-based diet indices was significantly associated with the risk for CRC in women, which could be because of different dietary habits between men and women, the researchers say.
In general, women consume more plant foods and less animal foods than men do, they point out.
In addition, women in the Multiethnic Cohort Study consumed higher amounts of healthy plant foods and lower amounts of less healthy plant foods compared with men, so they may not have further benefits with high scores of plant-based diet indices. Also, men are at higher risk for CRC than women are in general.
These findings suggest that the benefits from plant-based diets may vary by sex, race, and ethnicity, and anatomic subsite of tumor.
In men, the inverse association of overall PDI was greater in Japanese American, Native Hawaiian, and White groups than in African American and Latino groups, and for left colon and rectum tumors than for right colon tumors. The decreased risk with the hPDI was suggested across racial and ethnic groups and was observed for all tumor subsites.
“It was interesting to see that the association of a plant-based diet with CRC varied by race and ethnicity. It is not clear why. It could be nondietary lifestyle factors or genetic factors,” Ms. Kim told this news organization.
“We should investigate that more in the future,” Ms. Kim added.
By way of limitations, it’s possible that residual or unmeasured confounding might exist despite adjustment for key CRC risk factors, the researchers say. However, the subgroup analyses suggest that the impact of residual confounding due to body mass index, smoking status, and alcohol consumption was “minimal,” they note.
Another limitation is that the analysis was based on diet measured only at baseline, but dietary habits might change over time.
Overall, the findings “support that improving the quality of plant foods and reducing animal food consumption can help prevent colorectal cancer,” Ms. Kim and colleagues say.
The study was supported by the National Research Foundation of Korea and the U.S. National Cancer Institute and National Institutes of Health. The authors have declared no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
although the strength of the association may vary by race and ethnicity and tumor site, new research shows.
The “take-home message is that improving the quality of plant foods and reducing animal food consumption can help prevent colorectal cancer in men,” Jihye Kim told this news organization.
The findings suggest that “not all plant-based diets are the same with regard to colorectal cancer protection/risk,” said Ms. Kim, a professor in the College of Life and Sciences at Kyung Hee University in South Korea.
The study was published online in BMC Medicine.
The researchers investigated the risk for CRC in association with three plant-based dietary patterns defined by a priori indices: an overall plant-based diet index (PDI), a healthful plant-based diet index (hPDI), and an unhealthful plant-based diet index (uPDI).
All three indices negatively weigh animal foods but weigh plant foods differently depending on their nutritional quality.
Examples of foods contained in the hPDI include whole grains, fruits, vegetables, vegetable oils, nuts, legumes, tea, and coffee. Foods in the uPDI include refined grains, fruit juices, potatoes, and added sugars.
They calculated the PDI, hPDI, and uPDI using data from quantitative food frequency questionnaires provided by 79,952 men (mean age, 60 years at baseline) and 93,475 women (mean age, 59 years at baseline) in the Multiethnic Cohort Study.
During a mean follow-up of about 19 years, 4,976 participants developed CRC.
The plant-based diet indices were significantly inversely associated with the risk for CRC in men.
Researchers found that men with the greatest adherence to PDI and hPDI had a 24% (hazard ratio, 0.76) and 21% (HR, 0.79) lower risk for CRC, respectively, compared with men with the lowest adherence. No significant association was found between the risk for CRC in men and uPDI.
None of the plant-based diet indices was significantly associated with the risk for CRC in women, which could be because of different dietary habits between men and women, the researchers say.
In general, women consume more plant foods and less animal foods than men do, they point out.
In addition, women in the Multiethnic Cohort Study consumed higher amounts of healthy plant foods and lower amounts of less healthy plant foods compared with men, so they may not have further benefits with high scores of plant-based diet indices. Also, men are at higher risk for CRC than women are in general.
These findings suggest that the benefits from plant-based diets may vary by sex, race, and ethnicity, and anatomic subsite of tumor.
In men, the inverse association of overall PDI was greater in Japanese American, Native Hawaiian, and White groups than in African American and Latino groups, and for left colon and rectum tumors than for right colon tumors. The decreased risk with the hPDI was suggested across racial and ethnic groups and was observed for all tumor subsites.
“It was interesting to see that the association of a plant-based diet with CRC varied by race and ethnicity. It is not clear why. It could be nondietary lifestyle factors or genetic factors,” Ms. Kim told this news organization.
“We should investigate that more in the future,” Ms. Kim added.
By way of limitations, it’s possible that residual or unmeasured confounding might exist despite adjustment for key CRC risk factors, the researchers say. However, the subgroup analyses suggest that the impact of residual confounding due to body mass index, smoking status, and alcohol consumption was “minimal,” they note.
Another limitation is that the analysis was based on diet measured only at baseline, but dietary habits might change over time.
Overall, the findings “support that improving the quality of plant foods and reducing animal food consumption can help prevent colorectal cancer,” Ms. Kim and colleagues say.
The study was supported by the National Research Foundation of Korea and the U.S. National Cancer Institute and National Institutes of Health. The authors have declared no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM BMC MEDICINE
A new use for dating apps: Chasing STDs
Heather Meador and Anna Herber-Downey use dating apps on the job – and their boss knows it.
Both are public health nurses employed by Linn County Public Health in eastern Iowa. They’ve learned that dating apps are the most efficient way to inform users that people they previously met on the sites may have exposed them to sexually transmitted infections.
A nationwide surge in STIs, also known as STDs – with reported cases of gonorrhea and syphilis increasing 10% and 7%, respectively, from 2019 to 2020, according to the Centers for Disease Control and Prevention – isn’t sparing Iowa. The duo has found that the telephone call, a traditional method of contact tracing, no longer works well.
“When I started 12 years ago, we called everyone,” said Ms. Meador, the county health department’s clinical branch supervisor. “It’s getting harder and harder to just call someone on the phone.”
Even texting is ineffective, they said. And people aren’t necessarily answering messages on Facebook. The dating apps are where they’re at.
Because many people are meeting sex partners online – via sites like Grindr or Snapchat, which are headquartered in West Hollywood and Santa Monica, Calif., respectively – contact tracers often don’t have much information to go on, just a screen name or a picture.
So, about a year ago, Ms. Meador and her colleagues got approval from their bosses at the local level to build profiles on the app, through which they can contact the sex partners of infected people.
Traditionally, contact tracers interview people infected with an STI about their recent encounters and then reach out to those partners to tell them about the potential exposure.
Linn County contact tracers use the apps throughout their workday. Grindr, in particular, relies on geolocation, showing users matches who are close by. So the tracers use the apps when they’re out and about, hoping to wander into the same neighborhoods as the person diagnosed with an STI. Sometimes users “tap” the contract tracers to see whether they’re interested – in dating, that is.
When the public health officials spot someone they’re looking for, they send a message asking for a call. It’s a successful method: Ms. Herber-Downey estimated they make an initial contact 75% of the time.
Linn County’s decision to move online comes as STI rates rise nationally, funding to fight them falls, and people adopt new technologies to meet people and seek fun. “STIs are increasing way faster than the funding we have,” said Leo Parker, director of prevention programs for the National Coalition of STD Directors, all while public health departments – many underfunded – are grappling with new behaviors.
“Social media companies have billions; we have tens of thousands,” said Jeffrey Klausner, MD, MPH, a University of Southern California, Los Angeles, public health professor, who previously served as San Francisco’s director of STD prevention and control services. That funding disparity means few public health departments have staff members who can go online. “It’s only really in major cities that they have anyone who’s tasked for that,” Dr. Klausner said.
Even when departments have enough employees to take on the challenge, institutional support can be lacking. Some public health officials question employees who log into the apps. Dr. Klausner once testified on behalf of a Ventura County, Calif., contact tracer who was fired for using sex sites for work.
But with people migrating online to meet partners, following them there makes sense. “We’re now in a digital age,” Mr. Parker said. Individuals might not be out, or might be questioning their identity, making online venues comfortable, anonymous spaces for romance – which, in turn, means people are harder to reach face-to-face, at least at first.
What’s more, online spaces like Grindr are effective public health tools beyond contact tracing. They can be useful ways to get the word out about public health concerns.
Mr. Parker and the Linn County officials said public service announcements on dating apps – advocating for condom use or sharing the business hours for sexual health clinics – do seem to lead people to services. “We do have individuals coming in, saying, ‘I saw you had free testing. I saw it on Grindr,’ ” Mr. Parker said.
Grindr, which touts itself as the biggest dating app focused on LGBTQ+ people, pushes out messages and information to its members, said Jack Harrison-Quintana, director of Grindr for Equality. That engagement intensified during a 2015 meningitis outbreak among LGBTQ+ communities in Chicago, for example.
During that outbreak, the app sent citywide messages about vaccination. Then Mr. Harrison-Quintana took advantage of the service’s design: Using the site’s geolocating capabilities, Grindr workers targeted messages to specific neighborhoods. “We could go in and really go block to block and say, ‘Is this where the cases are showing up?’ ” he said. If so, they sent more messages to that area.
That campaign encouraged further efforts from the app, which regularly sends public health messages about everything from COVID-19 to monkeypox to the platform’s base of roughly 11 million monthly users. Grindr also allows users to display their HIV status and indicate whether they’re vaccinated against COVID, monkeypox, and meningitis.
There are a couple of things Grindr won’t do, however. The company won’t allow public health departments to create institutional accounts. And it won’t allow automated notifications about STI exposures to be sent to users.
That’s due to privacy concerns, the company said, despite calls from public health advocates to deploy better messaging features. Grindr believes that a government presence on the app would be too intrusive and that even anonymous notifications would allow users to trace infections back to their source. (When asked about public health officials who join the site on their own, company spokesperson Patrick Lenihan said: “Individuals are free to say something like ‘I’m a public health professional – ask me about my work!’ in their profile and are free to discuss sexual and public health matters however they see fit.”)
Grindr’s position – however disappointing to some in the public health world – reflects a longtime balancing act attempted by the private sector, which aims to square government concerns with users’ privacy interests.
Dr. Klausner pointed to a 1999 syphilis outbreak in San Francisco as one of the first times he saw how those interests could be at odds. The outbreak was traced to an AOL chatroom. Based on his research, Dr. Klausner said it seemed as though people could go online and “get a sex partner faster than you can get a pizza delivered.”
But persuading New York–based Time Warner, eventually AOL’s corporate parent, to cooperate was time-intensive and tricky – gaining entrée into the chatroom required help from the New York attorney general’s office.
The online industry has advanced since then, Dr. Klausner said. He helped one service develop a system to send digital postcards to potentially exposed people. “Congratulations, you got syphilis,” the postcards read. “They were edgy postcards,” he said, although some options were less “snarky.”
Overall, however, the dating app world is still “bifurcated,” he said. For public health efforts, apps that appeal to LGBTQ+ users are generally more helpful than those that predominantly cater to heterosexual clients.
That’s due to the community’s history with sexual health, explained Jen Hecht, a leader of Building Healthy Online Communities, a public health group partnering with dating apps. “Folks in the queer community have – what – 30, 40 years of thinking about HIV?” she said.
Even though STIs affect everyone, “the norm and the expectation is not there” for straight-focused dating apps, she said. Indeed, neither Match Group nor Bumble – the corporations with the biggest apps focused on heterosexual dating, both based in Texas – responded to multiple requests for comment from KHN.
But users, at least so far, seem to appreciate the app-based interventions. Mr. Harrison-Quintana said Grindr has landed on a just-the-facts approach to conveying health information. He has never received any backlash, “which has been very nice.”
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.
Heather Meador and Anna Herber-Downey use dating apps on the job – and their boss knows it.
Both are public health nurses employed by Linn County Public Health in eastern Iowa. They’ve learned that dating apps are the most efficient way to inform users that people they previously met on the sites may have exposed them to sexually transmitted infections.
A nationwide surge in STIs, also known as STDs – with reported cases of gonorrhea and syphilis increasing 10% and 7%, respectively, from 2019 to 2020, according to the Centers for Disease Control and Prevention – isn’t sparing Iowa. The duo has found that the telephone call, a traditional method of contact tracing, no longer works well.
“When I started 12 years ago, we called everyone,” said Ms. Meador, the county health department’s clinical branch supervisor. “It’s getting harder and harder to just call someone on the phone.”
Even texting is ineffective, they said. And people aren’t necessarily answering messages on Facebook. The dating apps are where they’re at.
Because many people are meeting sex partners online – via sites like Grindr or Snapchat, which are headquartered in West Hollywood and Santa Monica, Calif., respectively – contact tracers often don’t have much information to go on, just a screen name or a picture.
So, about a year ago, Ms. Meador and her colleagues got approval from their bosses at the local level to build profiles on the app, through which they can contact the sex partners of infected people.
Traditionally, contact tracers interview people infected with an STI about their recent encounters and then reach out to those partners to tell them about the potential exposure.
Linn County contact tracers use the apps throughout their workday. Grindr, in particular, relies on geolocation, showing users matches who are close by. So the tracers use the apps when they’re out and about, hoping to wander into the same neighborhoods as the person diagnosed with an STI. Sometimes users “tap” the contract tracers to see whether they’re interested – in dating, that is.
When the public health officials spot someone they’re looking for, they send a message asking for a call. It’s a successful method: Ms. Herber-Downey estimated they make an initial contact 75% of the time.
Linn County’s decision to move online comes as STI rates rise nationally, funding to fight them falls, and people adopt new technologies to meet people and seek fun. “STIs are increasing way faster than the funding we have,” said Leo Parker, director of prevention programs for the National Coalition of STD Directors, all while public health departments – many underfunded – are grappling with new behaviors.
“Social media companies have billions; we have tens of thousands,” said Jeffrey Klausner, MD, MPH, a University of Southern California, Los Angeles, public health professor, who previously served as San Francisco’s director of STD prevention and control services. That funding disparity means few public health departments have staff members who can go online. “It’s only really in major cities that they have anyone who’s tasked for that,” Dr. Klausner said.
Even when departments have enough employees to take on the challenge, institutional support can be lacking. Some public health officials question employees who log into the apps. Dr. Klausner once testified on behalf of a Ventura County, Calif., contact tracer who was fired for using sex sites for work.
But with people migrating online to meet partners, following them there makes sense. “We’re now in a digital age,” Mr. Parker said. Individuals might not be out, or might be questioning their identity, making online venues comfortable, anonymous spaces for romance – which, in turn, means people are harder to reach face-to-face, at least at first.
What’s more, online spaces like Grindr are effective public health tools beyond contact tracing. They can be useful ways to get the word out about public health concerns.
Mr. Parker and the Linn County officials said public service announcements on dating apps – advocating for condom use or sharing the business hours for sexual health clinics – do seem to lead people to services. “We do have individuals coming in, saying, ‘I saw you had free testing. I saw it on Grindr,’ ” Mr. Parker said.
Grindr, which touts itself as the biggest dating app focused on LGBTQ+ people, pushes out messages and information to its members, said Jack Harrison-Quintana, director of Grindr for Equality. That engagement intensified during a 2015 meningitis outbreak among LGBTQ+ communities in Chicago, for example.
During that outbreak, the app sent citywide messages about vaccination. Then Mr. Harrison-Quintana took advantage of the service’s design: Using the site’s geolocating capabilities, Grindr workers targeted messages to specific neighborhoods. “We could go in and really go block to block and say, ‘Is this where the cases are showing up?’ ” he said. If so, they sent more messages to that area.
That campaign encouraged further efforts from the app, which regularly sends public health messages about everything from COVID-19 to monkeypox to the platform’s base of roughly 11 million monthly users. Grindr also allows users to display their HIV status and indicate whether they’re vaccinated against COVID, monkeypox, and meningitis.
There are a couple of things Grindr won’t do, however. The company won’t allow public health departments to create institutional accounts. And it won’t allow automated notifications about STI exposures to be sent to users.
That’s due to privacy concerns, the company said, despite calls from public health advocates to deploy better messaging features. Grindr believes that a government presence on the app would be too intrusive and that even anonymous notifications would allow users to trace infections back to their source. (When asked about public health officials who join the site on their own, company spokesperson Patrick Lenihan said: “Individuals are free to say something like ‘I’m a public health professional – ask me about my work!’ in their profile and are free to discuss sexual and public health matters however they see fit.”)
Grindr’s position – however disappointing to some in the public health world – reflects a longtime balancing act attempted by the private sector, which aims to square government concerns with users’ privacy interests.
Dr. Klausner pointed to a 1999 syphilis outbreak in San Francisco as one of the first times he saw how those interests could be at odds. The outbreak was traced to an AOL chatroom. Based on his research, Dr. Klausner said it seemed as though people could go online and “get a sex partner faster than you can get a pizza delivered.”
But persuading New York–based Time Warner, eventually AOL’s corporate parent, to cooperate was time-intensive and tricky – gaining entrée into the chatroom required help from the New York attorney general’s office.
The online industry has advanced since then, Dr. Klausner said. He helped one service develop a system to send digital postcards to potentially exposed people. “Congratulations, you got syphilis,” the postcards read. “They were edgy postcards,” he said, although some options were less “snarky.”
Overall, however, the dating app world is still “bifurcated,” he said. For public health efforts, apps that appeal to LGBTQ+ users are generally more helpful than those that predominantly cater to heterosexual clients.
That’s due to the community’s history with sexual health, explained Jen Hecht, a leader of Building Healthy Online Communities, a public health group partnering with dating apps. “Folks in the queer community have – what – 30, 40 years of thinking about HIV?” she said.
Even though STIs affect everyone, “the norm and the expectation is not there” for straight-focused dating apps, she said. Indeed, neither Match Group nor Bumble – the corporations with the biggest apps focused on heterosexual dating, both based in Texas – responded to multiple requests for comment from KHN.
But users, at least so far, seem to appreciate the app-based interventions. Mr. Harrison-Quintana said Grindr has landed on a just-the-facts approach to conveying health information. He has never received any backlash, “which has been very nice.”
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.
Heather Meador and Anna Herber-Downey use dating apps on the job – and their boss knows it.
Both are public health nurses employed by Linn County Public Health in eastern Iowa. They’ve learned that dating apps are the most efficient way to inform users that people they previously met on the sites may have exposed them to sexually transmitted infections.
A nationwide surge in STIs, also known as STDs – with reported cases of gonorrhea and syphilis increasing 10% and 7%, respectively, from 2019 to 2020, according to the Centers for Disease Control and Prevention – isn’t sparing Iowa. The duo has found that the telephone call, a traditional method of contact tracing, no longer works well.
“When I started 12 years ago, we called everyone,” said Ms. Meador, the county health department’s clinical branch supervisor. “It’s getting harder and harder to just call someone on the phone.”
Even texting is ineffective, they said. And people aren’t necessarily answering messages on Facebook. The dating apps are where they’re at.
Because many people are meeting sex partners online – via sites like Grindr or Snapchat, which are headquartered in West Hollywood and Santa Monica, Calif., respectively – contact tracers often don’t have much information to go on, just a screen name or a picture.
So, about a year ago, Ms. Meador and her colleagues got approval from their bosses at the local level to build profiles on the app, through which they can contact the sex partners of infected people.
Traditionally, contact tracers interview people infected with an STI about their recent encounters and then reach out to those partners to tell them about the potential exposure.
Linn County contact tracers use the apps throughout their workday. Grindr, in particular, relies on geolocation, showing users matches who are close by. So the tracers use the apps when they’re out and about, hoping to wander into the same neighborhoods as the person diagnosed with an STI. Sometimes users “tap” the contract tracers to see whether they’re interested – in dating, that is.
When the public health officials spot someone they’re looking for, they send a message asking for a call. It’s a successful method: Ms. Herber-Downey estimated they make an initial contact 75% of the time.
Linn County’s decision to move online comes as STI rates rise nationally, funding to fight them falls, and people adopt new technologies to meet people and seek fun. “STIs are increasing way faster than the funding we have,” said Leo Parker, director of prevention programs for the National Coalition of STD Directors, all while public health departments – many underfunded – are grappling with new behaviors.
“Social media companies have billions; we have tens of thousands,” said Jeffrey Klausner, MD, MPH, a University of Southern California, Los Angeles, public health professor, who previously served as San Francisco’s director of STD prevention and control services. That funding disparity means few public health departments have staff members who can go online. “It’s only really in major cities that they have anyone who’s tasked for that,” Dr. Klausner said.
Even when departments have enough employees to take on the challenge, institutional support can be lacking. Some public health officials question employees who log into the apps. Dr. Klausner once testified on behalf of a Ventura County, Calif., contact tracer who was fired for using sex sites for work.
But with people migrating online to meet partners, following them there makes sense. “We’re now in a digital age,” Mr. Parker said. Individuals might not be out, or might be questioning their identity, making online venues comfortable, anonymous spaces for romance – which, in turn, means people are harder to reach face-to-face, at least at first.
What’s more, online spaces like Grindr are effective public health tools beyond contact tracing. They can be useful ways to get the word out about public health concerns.
Mr. Parker and the Linn County officials said public service announcements on dating apps – advocating for condom use or sharing the business hours for sexual health clinics – do seem to lead people to services. “We do have individuals coming in, saying, ‘I saw you had free testing. I saw it on Grindr,’ ” Mr. Parker said.
Grindr, which touts itself as the biggest dating app focused on LGBTQ+ people, pushes out messages and information to its members, said Jack Harrison-Quintana, director of Grindr for Equality. That engagement intensified during a 2015 meningitis outbreak among LGBTQ+ communities in Chicago, for example.
During that outbreak, the app sent citywide messages about vaccination. Then Mr. Harrison-Quintana took advantage of the service’s design: Using the site’s geolocating capabilities, Grindr workers targeted messages to specific neighborhoods. “We could go in and really go block to block and say, ‘Is this where the cases are showing up?’ ” he said. If so, they sent more messages to that area.
That campaign encouraged further efforts from the app, which regularly sends public health messages about everything from COVID-19 to monkeypox to the platform’s base of roughly 11 million monthly users. Grindr also allows users to display their HIV status and indicate whether they’re vaccinated against COVID, monkeypox, and meningitis.
There are a couple of things Grindr won’t do, however. The company won’t allow public health departments to create institutional accounts. And it won’t allow automated notifications about STI exposures to be sent to users.
That’s due to privacy concerns, the company said, despite calls from public health advocates to deploy better messaging features. Grindr believes that a government presence on the app would be too intrusive and that even anonymous notifications would allow users to trace infections back to their source. (When asked about public health officials who join the site on their own, company spokesperson Patrick Lenihan said: “Individuals are free to say something like ‘I’m a public health professional – ask me about my work!’ in their profile and are free to discuss sexual and public health matters however they see fit.”)
Grindr’s position – however disappointing to some in the public health world – reflects a longtime balancing act attempted by the private sector, which aims to square government concerns with users’ privacy interests.
Dr. Klausner pointed to a 1999 syphilis outbreak in San Francisco as one of the first times he saw how those interests could be at odds. The outbreak was traced to an AOL chatroom. Based on his research, Dr. Klausner said it seemed as though people could go online and “get a sex partner faster than you can get a pizza delivered.”
But persuading New York–based Time Warner, eventually AOL’s corporate parent, to cooperate was time-intensive and tricky – gaining entrée into the chatroom required help from the New York attorney general’s office.
The online industry has advanced since then, Dr. Klausner said. He helped one service develop a system to send digital postcards to potentially exposed people. “Congratulations, you got syphilis,” the postcards read. “They were edgy postcards,” he said, although some options were less “snarky.”
Overall, however, the dating app world is still “bifurcated,” he said. For public health efforts, apps that appeal to LGBTQ+ users are generally more helpful than those that predominantly cater to heterosexual clients.
That’s due to the community’s history with sexual health, explained Jen Hecht, a leader of Building Healthy Online Communities, a public health group partnering with dating apps. “Folks in the queer community have – what – 30, 40 years of thinking about HIV?” she said.
Even though STIs affect everyone, “the norm and the expectation is not there” for straight-focused dating apps, she said. Indeed, neither Match Group nor Bumble – the corporations with the biggest apps focused on heterosexual dating, both based in Texas – responded to multiple requests for comment from KHN.
But users, at least so far, seem to appreciate the app-based interventions. Mr. Harrison-Quintana said Grindr has landed on a just-the-facts approach to conveying health information. He has never received any backlash, “which has been very nice.”
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.
HIV prevention: Clinician attitudes may be curtailing PrEP use
Taking an antiretroviral tablet daily for preexposure prophylaxis (PrEP) has been shown to be a safe and effective method of HIV prevention. However, low and variable uptake of PrEP among men who have sex with men (MSM) remains concerning.
Lead author Samuel R. Bunting, MD, and colleagues explored whether the attitudes of prescribing clinicians are impeding access to PrEP among MSM in the United States. They sought to understand whether clinician biases and expectations about race, HIV risk, adherence, and condom use might be affecting willingness to prescribe PrEP to a patient who specifically requests it.
They reached out to 16 U.S. medical schools (allopathic and osteopathic) with a combined total of 12,660 students. A total of 1,592 students indicated interest in participating in the study, and 600 completed it accurately.
Researchers simulated an electronic medical record for a fictional patient: a sexually active cisgender MSM presenting to a primary care physician and directly requesting access to PrEP for the first time. The simulated record included an uncomplicated medical history and lab results indicating that the patient was negative for HIV and other STIs.
Researchers systematically varied key aspects of the fictional patient, including his race (White or Black) and his intentions for future condom use if prescribed PrEP (continue using, unlikely to begin using, or will stop using). They asked the medical students a series of questions about their hypothetical patient interaction, including assessing patient HIV risk and provider willingness to prescribe PrEP.
The simulated medical records randomly included Black and White patients.
Dr. Bunting and coauthors found that the medical students were significantly less likely to indicate that they would prescribe PrEP to a patient described as “intending to discontinue” condom use were he to be prescribed PrEP, compared with patients “intending to continue” former practices of condom use or nonuse. On a scale from 1 (least likely to prescribe) to 7 (most likely to prescribe), willingness to prescribe was highest for the continued-nonuse group (mean score 6.35; 95% confidence interval, 6.18-6.52) and was lower for the planned-discontinuation group (mean score 5.91; 95% CI, 5.75-6.08; P = .001).
This finding reflects a prevailing fear of “risk compensation” – the concern that an individual on PrEP may start to take additional compensatory risks in his HIV exposures, including discontinuing condom use or increasing number of sexual partners.
In an interview with this news organization, Julia Marcus, PhD, MPH, an associate professor in the department of population medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, said: “These provider concerns [about risk compensation] are missing the mark. Just like oral contraception, the whole point of a prevention tool like PrEP is to allow people to engage in certain behaviors more safely. Rather than an unwanted consequence, behavior change may be the intended goal.” Dr. Marcus was not involved in the study.
Prior research has shown that uptake of PrEP among Black MSM is significantly lower than among White MSM in the United States. But this study showed no associations with patient race. However, Dr. Bunting and his coauthors found a troubling association with the personal attitudes of the medical students toward sexual activity: The more likely the medical students were to disapprove of nonmonogamy, the more likely they were to assume the possibility of future nonadherence to PrEP and to hesitate before prescribing PrEP.
Were the medical students making assumptions about patients’ ability to be faithful and consistent, whether to a partner or to a drug regimen? Either way, provider hesitancy to prescribe PrEP to a patient on the basis of their stated intention to discontinue condom use or because of the clinician’s own internalized biases about nonmonogamous relationships both represent troubling barriers to accessing clinical care, reinforcing the clinician’s role as gatekeeper to PrEP.
“It’s frustrating that these biases are still in play and potentially contributing to slow and inequitable PrEP uptake” Dr. Marcus commented. “Every sexually active primary care patient should be informed about PrEP, in accordance with CDC guidance, but providers often feel constrained by time ... We need tools that can normalize PrEP in primary care and help limit the potential effect of biases on PrEP prescribing decisions.”
In an interview, Dr. Bunting, resident physician in the department of psychiatry and behavioral neuroscience at University of Chicago Medicine, said in an interview, “Condom use has long been a stalwart prevention mechanism, but PrEP offers superior protection and patients who are seeking PrEP are exhibiting agency and informed risk mitigation ... When a patient is seeking additional protection, it is less about what is the right way to experience a sexual relationship, and more about what is the right way to be safe from HIV.”
Although this study has a number of limitations, including the fact that it is based on a controlled and hypothetical scenario and study participants are still medical students not yet licensed to prescribe, its results have important implications: It underscores the need to train clinicians to recognize and set aside their own social biases during clinical interactions.
Bunting suggested that provider training should support clinicians to evaluate patient requests in a nonjudgmental, pragmatic, and realistic manner appropriately reflecting patient informed agency and knowledge of their own risk factors.
And Dr. Marcus concurred, noting that standardizing the delivery of PrEP through a screening algorithm presents an alternative pathway for eliminating the role of stigmatizing clinician biases and working toward equitable access to PrEP.
This study was supported by unrestricted research funding from Gilead Sciences. The funder had no input into research design, implementation, analysis, interpretation, or publication decisions. Coauthor Brian A. Feinstein’s time was supported by a grant from the National Institute on Drug Abuse. No additional funding was received to support this research.
A version of this article first appeared on Medscape.com.
Taking an antiretroviral tablet daily for preexposure prophylaxis (PrEP) has been shown to be a safe and effective method of HIV prevention. However, low and variable uptake of PrEP among men who have sex with men (MSM) remains concerning.
Lead author Samuel R. Bunting, MD, and colleagues explored whether the attitudes of prescribing clinicians are impeding access to PrEP among MSM in the United States. They sought to understand whether clinician biases and expectations about race, HIV risk, adherence, and condom use might be affecting willingness to prescribe PrEP to a patient who specifically requests it.
They reached out to 16 U.S. medical schools (allopathic and osteopathic) with a combined total of 12,660 students. A total of 1,592 students indicated interest in participating in the study, and 600 completed it accurately.
Researchers simulated an electronic medical record for a fictional patient: a sexually active cisgender MSM presenting to a primary care physician and directly requesting access to PrEP for the first time. The simulated record included an uncomplicated medical history and lab results indicating that the patient was negative for HIV and other STIs.
Researchers systematically varied key aspects of the fictional patient, including his race (White or Black) and his intentions for future condom use if prescribed PrEP (continue using, unlikely to begin using, or will stop using). They asked the medical students a series of questions about their hypothetical patient interaction, including assessing patient HIV risk and provider willingness to prescribe PrEP.
The simulated medical records randomly included Black and White patients.
Dr. Bunting and coauthors found that the medical students were significantly less likely to indicate that they would prescribe PrEP to a patient described as “intending to discontinue” condom use were he to be prescribed PrEP, compared with patients “intending to continue” former practices of condom use or nonuse. On a scale from 1 (least likely to prescribe) to 7 (most likely to prescribe), willingness to prescribe was highest for the continued-nonuse group (mean score 6.35; 95% confidence interval, 6.18-6.52) and was lower for the planned-discontinuation group (mean score 5.91; 95% CI, 5.75-6.08; P = .001).
This finding reflects a prevailing fear of “risk compensation” – the concern that an individual on PrEP may start to take additional compensatory risks in his HIV exposures, including discontinuing condom use or increasing number of sexual partners.
In an interview with this news organization, Julia Marcus, PhD, MPH, an associate professor in the department of population medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, said: “These provider concerns [about risk compensation] are missing the mark. Just like oral contraception, the whole point of a prevention tool like PrEP is to allow people to engage in certain behaviors more safely. Rather than an unwanted consequence, behavior change may be the intended goal.” Dr. Marcus was not involved in the study.
Prior research has shown that uptake of PrEP among Black MSM is significantly lower than among White MSM in the United States. But this study showed no associations with patient race. However, Dr. Bunting and his coauthors found a troubling association with the personal attitudes of the medical students toward sexual activity: The more likely the medical students were to disapprove of nonmonogamy, the more likely they were to assume the possibility of future nonadherence to PrEP and to hesitate before prescribing PrEP.
Were the medical students making assumptions about patients’ ability to be faithful and consistent, whether to a partner or to a drug regimen? Either way, provider hesitancy to prescribe PrEP to a patient on the basis of their stated intention to discontinue condom use or because of the clinician’s own internalized biases about nonmonogamous relationships both represent troubling barriers to accessing clinical care, reinforcing the clinician’s role as gatekeeper to PrEP.
“It’s frustrating that these biases are still in play and potentially contributing to slow and inequitable PrEP uptake” Dr. Marcus commented. “Every sexually active primary care patient should be informed about PrEP, in accordance with CDC guidance, but providers often feel constrained by time ... We need tools that can normalize PrEP in primary care and help limit the potential effect of biases on PrEP prescribing decisions.”
In an interview, Dr. Bunting, resident physician in the department of psychiatry and behavioral neuroscience at University of Chicago Medicine, said in an interview, “Condom use has long been a stalwart prevention mechanism, but PrEP offers superior protection and patients who are seeking PrEP are exhibiting agency and informed risk mitigation ... When a patient is seeking additional protection, it is less about what is the right way to experience a sexual relationship, and more about what is the right way to be safe from HIV.”
Although this study has a number of limitations, including the fact that it is based on a controlled and hypothetical scenario and study participants are still medical students not yet licensed to prescribe, its results have important implications: It underscores the need to train clinicians to recognize and set aside their own social biases during clinical interactions.
Bunting suggested that provider training should support clinicians to evaluate patient requests in a nonjudgmental, pragmatic, and realistic manner appropriately reflecting patient informed agency and knowledge of their own risk factors.
And Dr. Marcus concurred, noting that standardizing the delivery of PrEP through a screening algorithm presents an alternative pathway for eliminating the role of stigmatizing clinician biases and working toward equitable access to PrEP.
This study was supported by unrestricted research funding from Gilead Sciences. The funder had no input into research design, implementation, analysis, interpretation, or publication decisions. Coauthor Brian A. Feinstein’s time was supported by a grant from the National Institute on Drug Abuse. No additional funding was received to support this research.
A version of this article first appeared on Medscape.com.
Taking an antiretroviral tablet daily for preexposure prophylaxis (PrEP) has been shown to be a safe and effective method of HIV prevention. However, low and variable uptake of PrEP among men who have sex with men (MSM) remains concerning.
Lead author Samuel R. Bunting, MD, and colleagues explored whether the attitudes of prescribing clinicians are impeding access to PrEP among MSM in the United States. They sought to understand whether clinician biases and expectations about race, HIV risk, adherence, and condom use might be affecting willingness to prescribe PrEP to a patient who specifically requests it.
They reached out to 16 U.S. medical schools (allopathic and osteopathic) with a combined total of 12,660 students. A total of 1,592 students indicated interest in participating in the study, and 600 completed it accurately.
Researchers simulated an electronic medical record for a fictional patient: a sexually active cisgender MSM presenting to a primary care physician and directly requesting access to PrEP for the first time. The simulated record included an uncomplicated medical history and lab results indicating that the patient was negative for HIV and other STIs.
Researchers systematically varied key aspects of the fictional patient, including his race (White or Black) and his intentions for future condom use if prescribed PrEP (continue using, unlikely to begin using, or will stop using). They asked the medical students a series of questions about their hypothetical patient interaction, including assessing patient HIV risk and provider willingness to prescribe PrEP.
The simulated medical records randomly included Black and White patients.
Dr. Bunting and coauthors found that the medical students were significantly less likely to indicate that they would prescribe PrEP to a patient described as “intending to discontinue” condom use were he to be prescribed PrEP, compared with patients “intending to continue” former practices of condom use or nonuse. On a scale from 1 (least likely to prescribe) to 7 (most likely to prescribe), willingness to prescribe was highest for the continued-nonuse group (mean score 6.35; 95% confidence interval, 6.18-6.52) and was lower for the planned-discontinuation group (mean score 5.91; 95% CI, 5.75-6.08; P = .001).
This finding reflects a prevailing fear of “risk compensation” – the concern that an individual on PrEP may start to take additional compensatory risks in his HIV exposures, including discontinuing condom use or increasing number of sexual partners.
In an interview with this news organization, Julia Marcus, PhD, MPH, an associate professor in the department of population medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, said: “These provider concerns [about risk compensation] are missing the mark. Just like oral contraception, the whole point of a prevention tool like PrEP is to allow people to engage in certain behaviors more safely. Rather than an unwanted consequence, behavior change may be the intended goal.” Dr. Marcus was not involved in the study.
Prior research has shown that uptake of PrEP among Black MSM is significantly lower than among White MSM in the United States. But this study showed no associations with patient race. However, Dr. Bunting and his coauthors found a troubling association with the personal attitudes of the medical students toward sexual activity: The more likely the medical students were to disapprove of nonmonogamy, the more likely they were to assume the possibility of future nonadherence to PrEP and to hesitate before prescribing PrEP.
Were the medical students making assumptions about patients’ ability to be faithful and consistent, whether to a partner or to a drug regimen? Either way, provider hesitancy to prescribe PrEP to a patient on the basis of their stated intention to discontinue condom use or because of the clinician’s own internalized biases about nonmonogamous relationships both represent troubling barriers to accessing clinical care, reinforcing the clinician’s role as gatekeeper to PrEP.
“It’s frustrating that these biases are still in play and potentially contributing to slow and inequitable PrEP uptake” Dr. Marcus commented. “Every sexually active primary care patient should be informed about PrEP, in accordance with CDC guidance, but providers often feel constrained by time ... We need tools that can normalize PrEP in primary care and help limit the potential effect of biases on PrEP prescribing decisions.”
In an interview, Dr. Bunting, resident physician in the department of psychiatry and behavioral neuroscience at University of Chicago Medicine, said in an interview, “Condom use has long been a stalwart prevention mechanism, but PrEP offers superior protection and patients who are seeking PrEP are exhibiting agency and informed risk mitigation ... When a patient is seeking additional protection, it is less about what is the right way to experience a sexual relationship, and more about what is the right way to be safe from HIV.”
Although this study has a number of limitations, including the fact that it is based on a controlled and hypothetical scenario and study participants are still medical students not yet licensed to prescribe, its results have important implications: It underscores the need to train clinicians to recognize and set aside their own social biases during clinical interactions.
Bunting suggested that provider training should support clinicians to evaluate patient requests in a nonjudgmental, pragmatic, and realistic manner appropriately reflecting patient informed agency and knowledge of their own risk factors.
And Dr. Marcus concurred, noting that standardizing the delivery of PrEP through a screening algorithm presents an alternative pathway for eliminating the role of stigmatizing clinician biases and working toward equitable access to PrEP.
This study was supported by unrestricted research funding from Gilead Sciences. The funder had no input into research design, implementation, analysis, interpretation, or publication decisions. Coauthor Brian A. Feinstein’s time was supported by a grant from the National Institute on Drug Abuse. No additional funding was received to support this research.
A version of this article first appeared on Medscape.com.
FROM JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROME
As STDs proliferate, companies rush to market at-home test kits. But are they reliable?
Among the more remarkable legacies of the COVID-19 pandemic is how quickly federal regulators, the health care industry, and consumers moved to make at-home testing a reliable tool for managing a public health crisis.
But that fast-track focus is missing from another, less publicized epidemic: an explosion in sexually transmitted diseases that can cause chronic pain and infertility among infected adults and disable or kill infected newborns. The disparity has amplified calls from researchers, public health advocates, and health care companies urging the federal government to greenlight at-home testing kits that could vastly multiply the number of Americans testing for STDs.
Online shoppers can already choose from more than a dozen self-testing kits, typically ranging in price from $69 to $500, depending on the brand and the variety of infections they can detect.
But, except for HIV tests, the Food and Drug Administration hasn’t approved STD test kits for use outside a medical setting. That leaves consumers unsure about their reliability even as at-home use grows dramatically.
The STD epidemic is “out of control,” said Amesh Adalja, MD, a senior scholar at the Johns Hopkins University Center for Health Security. “We know we are missing diagnoses. We know that contact tracing is happening late or not at all. If we’re really serious about tackling the STD crisis, we have to get more people diagnosed.”
Preliminary data for 2021 showed nearly 2.5 million reported cases of chlamydia, gonorrhea, and syphilis in the United States, according to the Centers for Disease Control and Prevention. Reported cases of syphilis and gonorrhea have been climbing for about a decade. In its most recent prevalence estimate, the agency said that on any given day, one in five Americans are infected with any of eight common STDs.
The push to make at-home testing for STDs as easy and commonplace as at-home COVID and pregnancy testing is coming from several sectors. Public health officials say their overextended staffers can’t handle the staggering need for testing and surveillance. Diagnostic and pharmaceutical companies see a business opportunity in the unmet demand.
The medical science underpinning STD testing is not particularly new or mysterious. Depending on the test, it may involve collecting a urine sample, pricking a finger for blood, or swabbing the mouth, genitals, or anus for discharge or cell samples. Medical centers and community health clinics have performed such testing for decades.
The issue for regulators is whether sampling kits can be reliably adapted for in-home use. Unlike rapid antigen tests for COVID, which produce results in 15-20 minutes, the home STD kits on the market require patients to collect their own samples, and then package and mail them to a lab for analysis.
In the past 3 years, as the pandemic prompted clinics that provide low-cost care to drastically curtail in-person services, a number of public health departments – among them state agencies in Alabama, Alaska, and Maryland – have started mailing free STD test kits to residents. Universities and nonprofits are also spearheading at-home testing efforts.
And dozens of commercial enterprises are jumping into or ramping up direct-to-consumer sales. Everly Health, a digital health company that sells a variety of lab tests online, reported sales for its suite of STD kits grew 120% in the first half of this year compared with the first half of 2021.
CVS Health began selling its own bundled STD kit in October, priced at $99.99. Unlike most home kits, CVS’ version is available in stores.
Hologic, Abbott, and Molecular Testing Labs are among the companies urgently developing tests. And Cue Health, which sells COVID tests, is poised to launch a clinical trial for a rapid home test for chlamydia and gonorrhea that would set a new bar, providing results in about 20 minutes.
Alberto Gutierrez, who formerly led the FDA office that oversees diagnostic tests, said agency officials have been concerned about the reliability of home tests for years. The FDA wants companies to prove that home collection kits are as accurate as those used in clinics, and that samples don’t degrade during shipping.
“The agency doesn’t believe these tests are legally marketed at this point,” said Mr. Gutierrez, a partner at NDA Partners, a consulting firm that advises companies seeking to bring health care products to market.
“CVS should not be selling that test,” he added.
In response to KHN questions, the FDA said it considers home collection kits, which can include swabs, lancets, transport tubes, and chemicals to stabilize the samples, to be devices that require agency review. The FDA “generally does not comment” on whether it plans to take action on any specific case, the statement said.
CVS spokesperson Mary Gattuso said the pharmacy chain is following the law. “We are committed to ensuring the products we offer are safe, work as intended, comply with regulations, and satisfy customers,” Ms. Gattuso said.
Everly Health and other companies described their kits as laboratory-developed tests, akin to the diagnostics some hospitals create for in-house use. And they contend their tests can be legally marketed because their labs have been certified by a different agency, the Centers for Medicare & Medicaid Services.
“The instruments and assays used by the laboratories we use are comparable to – and often the same as – those used by the labs a doctor’s office uses,” said Liz Kwo, MD, chief medical officer at Everly Health. “Our at-home sample collection methods, like dried blood spots and saliva, have been widely used for decades.”
Home collection kits appeal to Uxmal Caldera, 27, of Miami Beach, who prefers to test in the privacy of his home. Mr. Caldera, who doesn’t have a car, said home testing saves him the time and expense of getting to a clinic.
Mr. Caldera has been testing himself for HIV and other STDs every 3 months for more than a year, part of routine monitoring for people taking PrEP, a regimen of daily pills to prevent HIV infection.
“Doing it by yourself is not hard at all,” said Mr. Caldera, who is uninsured but receives the tests free through a community foundation. “The instructions are really clear. I get the results in maybe 4 days. For sure, I would recommend it to other people.”
Leandro Mena, MD, director of the CDC’s division of STD prevention, said he would like to see at-home STD testing become as routine as home pregnancy tests. An estimated 16 million–20 million tests for gonorrhea and chlamydia are performed in the United States each year, Dr. Mena said. Widespread use of at-home STD testing could double or triple that number.
He noted that doctors have years of experience using home collection kits.
The Johns Hopkins Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases has distributed roughly 23,000 at-home STD kits since 2004, said Charlotte Gaydos, DrPH, a principal investigator with the center. The FDA generally allows such use if it’s part of research overseen by medical professionals. The center’s tests are now used by the Alaska health department, as well as Native American tribes in Arizona and Oklahoma.
Dr. Gaydos has published dozens of studies establishing that home collection kits for diseases such as chlamydia and gonorrhea are accurate and easy to use.
“There’s a huge amount of data showing that home testing works,” said Dr. Gaydos.
But Dr. Gaydos noted that her studies have been limited to small sample sizes. She said she doesn’t have the millions of dollars in funding it would take to run the sort of comprehensive trial the FDA typically requires for approval.
Jenny Mahn, director of clinical and sexual health at the National Coalition of STD Directors, said many public health labs are reluctant to handle home kits. “The public health labs won’t touch it without FDA’s blessing.”
Public health clinics often provide STD testing at little to no cost, while health insurance typically covers in-person testing at a private practice. But most consumers pay out-of-pocket for direct-to-consumer kits. Commercial pricing puts them out of reach for many people, particularly teens and young adults, who account for nearly half of STDs.
Adalja said the FDA has a history of moving slowly on home testing. The agency spent 7 years evaluating the first home HIV test it approved, which hit the market in 2012.
“Home testing is the way of the future,” said Laura Lindberg, PhD, a professor of public health at Rutgers University, Piscataway, N.J. “The pandemic opened the door to testing and treatment at home without traveling to a health care provider, and we aren’t going to be able to put the genie back in the bottle.”
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.
Among the more remarkable legacies of the COVID-19 pandemic is how quickly federal regulators, the health care industry, and consumers moved to make at-home testing a reliable tool for managing a public health crisis.
But that fast-track focus is missing from another, less publicized epidemic: an explosion in sexually transmitted diseases that can cause chronic pain and infertility among infected adults and disable or kill infected newborns. The disparity has amplified calls from researchers, public health advocates, and health care companies urging the federal government to greenlight at-home testing kits that could vastly multiply the number of Americans testing for STDs.
Online shoppers can already choose from more than a dozen self-testing kits, typically ranging in price from $69 to $500, depending on the brand and the variety of infections they can detect.
But, except for HIV tests, the Food and Drug Administration hasn’t approved STD test kits for use outside a medical setting. That leaves consumers unsure about their reliability even as at-home use grows dramatically.
The STD epidemic is “out of control,” said Amesh Adalja, MD, a senior scholar at the Johns Hopkins University Center for Health Security. “We know we are missing diagnoses. We know that contact tracing is happening late or not at all. If we’re really serious about tackling the STD crisis, we have to get more people diagnosed.”
Preliminary data for 2021 showed nearly 2.5 million reported cases of chlamydia, gonorrhea, and syphilis in the United States, according to the Centers for Disease Control and Prevention. Reported cases of syphilis and gonorrhea have been climbing for about a decade. In its most recent prevalence estimate, the agency said that on any given day, one in five Americans are infected with any of eight common STDs.
The push to make at-home testing for STDs as easy and commonplace as at-home COVID and pregnancy testing is coming from several sectors. Public health officials say their overextended staffers can’t handle the staggering need for testing and surveillance. Diagnostic and pharmaceutical companies see a business opportunity in the unmet demand.
The medical science underpinning STD testing is not particularly new or mysterious. Depending on the test, it may involve collecting a urine sample, pricking a finger for blood, or swabbing the mouth, genitals, or anus for discharge or cell samples. Medical centers and community health clinics have performed such testing for decades.
The issue for regulators is whether sampling kits can be reliably adapted for in-home use. Unlike rapid antigen tests for COVID, which produce results in 15-20 minutes, the home STD kits on the market require patients to collect their own samples, and then package and mail them to a lab for analysis.
In the past 3 years, as the pandemic prompted clinics that provide low-cost care to drastically curtail in-person services, a number of public health departments – among them state agencies in Alabama, Alaska, and Maryland – have started mailing free STD test kits to residents. Universities and nonprofits are also spearheading at-home testing efforts.
And dozens of commercial enterprises are jumping into or ramping up direct-to-consumer sales. Everly Health, a digital health company that sells a variety of lab tests online, reported sales for its suite of STD kits grew 120% in the first half of this year compared with the first half of 2021.
CVS Health began selling its own bundled STD kit in October, priced at $99.99. Unlike most home kits, CVS’ version is available in stores.
Hologic, Abbott, and Molecular Testing Labs are among the companies urgently developing tests. And Cue Health, which sells COVID tests, is poised to launch a clinical trial for a rapid home test for chlamydia and gonorrhea that would set a new bar, providing results in about 20 minutes.
Alberto Gutierrez, who formerly led the FDA office that oversees diagnostic tests, said agency officials have been concerned about the reliability of home tests for years. The FDA wants companies to prove that home collection kits are as accurate as those used in clinics, and that samples don’t degrade during shipping.
“The agency doesn’t believe these tests are legally marketed at this point,” said Mr. Gutierrez, a partner at NDA Partners, a consulting firm that advises companies seeking to bring health care products to market.
“CVS should not be selling that test,” he added.
In response to KHN questions, the FDA said it considers home collection kits, which can include swabs, lancets, transport tubes, and chemicals to stabilize the samples, to be devices that require agency review. The FDA “generally does not comment” on whether it plans to take action on any specific case, the statement said.
CVS spokesperson Mary Gattuso said the pharmacy chain is following the law. “We are committed to ensuring the products we offer are safe, work as intended, comply with regulations, and satisfy customers,” Ms. Gattuso said.
Everly Health and other companies described their kits as laboratory-developed tests, akin to the diagnostics some hospitals create for in-house use. And they contend their tests can be legally marketed because their labs have been certified by a different agency, the Centers for Medicare & Medicaid Services.
“The instruments and assays used by the laboratories we use are comparable to – and often the same as – those used by the labs a doctor’s office uses,” said Liz Kwo, MD, chief medical officer at Everly Health. “Our at-home sample collection methods, like dried blood spots and saliva, have been widely used for decades.”
Home collection kits appeal to Uxmal Caldera, 27, of Miami Beach, who prefers to test in the privacy of his home. Mr. Caldera, who doesn’t have a car, said home testing saves him the time and expense of getting to a clinic.
Mr. Caldera has been testing himself for HIV and other STDs every 3 months for more than a year, part of routine monitoring for people taking PrEP, a regimen of daily pills to prevent HIV infection.
“Doing it by yourself is not hard at all,” said Mr. Caldera, who is uninsured but receives the tests free through a community foundation. “The instructions are really clear. I get the results in maybe 4 days. For sure, I would recommend it to other people.”
Leandro Mena, MD, director of the CDC’s division of STD prevention, said he would like to see at-home STD testing become as routine as home pregnancy tests. An estimated 16 million–20 million tests for gonorrhea and chlamydia are performed in the United States each year, Dr. Mena said. Widespread use of at-home STD testing could double or triple that number.
He noted that doctors have years of experience using home collection kits.
The Johns Hopkins Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases has distributed roughly 23,000 at-home STD kits since 2004, said Charlotte Gaydos, DrPH, a principal investigator with the center. The FDA generally allows such use if it’s part of research overseen by medical professionals. The center’s tests are now used by the Alaska health department, as well as Native American tribes in Arizona and Oklahoma.
Dr. Gaydos has published dozens of studies establishing that home collection kits for diseases such as chlamydia and gonorrhea are accurate and easy to use.
“There’s a huge amount of data showing that home testing works,” said Dr. Gaydos.
But Dr. Gaydos noted that her studies have been limited to small sample sizes. She said she doesn’t have the millions of dollars in funding it would take to run the sort of comprehensive trial the FDA typically requires for approval.
Jenny Mahn, director of clinical and sexual health at the National Coalition of STD Directors, said many public health labs are reluctant to handle home kits. “The public health labs won’t touch it without FDA’s blessing.”
Public health clinics often provide STD testing at little to no cost, while health insurance typically covers in-person testing at a private practice. But most consumers pay out-of-pocket for direct-to-consumer kits. Commercial pricing puts them out of reach for many people, particularly teens and young adults, who account for nearly half of STDs.
Adalja said the FDA has a history of moving slowly on home testing. The agency spent 7 years evaluating the first home HIV test it approved, which hit the market in 2012.
“Home testing is the way of the future,” said Laura Lindberg, PhD, a professor of public health at Rutgers University, Piscataway, N.J. “The pandemic opened the door to testing and treatment at home without traveling to a health care provider, and we aren’t going to be able to put the genie back in the bottle.”
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.
Among the more remarkable legacies of the COVID-19 pandemic is how quickly federal regulators, the health care industry, and consumers moved to make at-home testing a reliable tool for managing a public health crisis.
But that fast-track focus is missing from another, less publicized epidemic: an explosion in sexually transmitted diseases that can cause chronic pain and infertility among infected adults and disable or kill infected newborns. The disparity has amplified calls from researchers, public health advocates, and health care companies urging the federal government to greenlight at-home testing kits that could vastly multiply the number of Americans testing for STDs.
Online shoppers can already choose from more than a dozen self-testing kits, typically ranging in price from $69 to $500, depending on the brand and the variety of infections they can detect.
But, except for HIV tests, the Food and Drug Administration hasn’t approved STD test kits for use outside a medical setting. That leaves consumers unsure about their reliability even as at-home use grows dramatically.
The STD epidemic is “out of control,” said Amesh Adalja, MD, a senior scholar at the Johns Hopkins University Center for Health Security. “We know we are missing diagnoses. We know that contact tracing is happening late or not at all. If we’re really serious about tackling the STD crisis, we have to get more people diagnosed.”
Preliminary data for 2021 showed nearly 2.5 million reported cases of chlamydia, gonorrhea, and syphilis in the United States, according to the Centers for Disease Control and Prevention. Reported cases of syphilis and gonorrhea have been climbing for about a decade. In its most recent prevalence estimate, the agency said that on any given day, one in five Americans are infected with any of eight common STDs.
The push to make at-home testing for STDs as easy and commonplace as at-home COVID and pregnancy testing is coming from several sectors. Public health officials say their overextended staffers can’t handle the staggering need for testing and surveillance. Diagnostic and pharmaceutical companies see a business opportunity in the unmet demand.
The medical science underpinning STD testing is not particularly new or mysterious. Depending on the test, it may involve collecting a urine sample, pricking a finger for blood, or swabbing the mouth, genitals, or anus for discharge or cell samples. Medical centers and community health clinics have performed such testing for decades.
The issue for regulators is whether sampling kits can be reliably adapted for in-home use. Unlike rapid antigen tests for COVID, which produce results in 15-20 minutes, the home STD kits on the market require patients to collect their own samples, and then package and mail them to a lab for analysis.
In the past 3 years, as the pandemic prompted clinics that provide low-cost care to drastically curtail in-person services, a number of public health departments – among them state agencies in Alabama, Alaska, and Maryland – have started mailing free STD test kits to residents. Universities and nonprofits are also spearheading at-home testing efforts.
And dozens of commercial enterprises are jumping into or ramping up direct-to-consumer sales. Everly Health, a digital health company that sells a variety of lab tests online, reported sales for its suite of STD kits grew 120% in the first half of this year compared with the first half of 2021.
CVS Health began selling its own bundled STD kit in October, priced at $99.99. Unlike most home kits, CVS’ version is available in stores.
Hologic, Abbott, and Molecular Testing Labs are among the companies urgently developing tests. And Cue Health, which sells COVID tests, is poised to launch a clinical trial for a rapid home test for chlamydia and gonorrhea that would set a new bar, providing results in about 20 minutes.
Alberto Gutierrez, who formerly led the FDA office that oversees diagnostic tests, said agency officials have been concerned about the reliability of home tests for years. The FDA wants companies to prove that home collection kits are as accurate as those used in clinics, and that samples don’t degrade during shipping.
“The agency doesn’t believe these tests are legally marketed at this point,” said Mr. Gutierrez, a partner at NDA Partners, a consulting firm that advises companies seeking to bring health care products to market.
“CVS should not be selling that test,” he added.
In response to KHN questions, the FDA said it considers home collection kits, which can include swabs, lancets, transport tubes, and chemicals to stabilize the samples, to be devices that require agency review. The FDA “generally does not comment” on whether it plans to take action on any specific case, the statement said.
CVS spokesperson Mary Gattuso said the pharmacy chain is following the law. “We are committed to ensuring the products we offer are safe, work as intended, comply with regulations, and satisfy customers,” Ms. Gattuso said.
Everly Health and other companies described their kits as laboratory-developed tests, akin to the diagnostics some hospitals create for in-house use. And they contend their tests can be legally marketed because their labs have been certified by a different agency, the Centers for Medicare & Medicaid Services.
“The instruments and assays used by the laboratories we use are comparable to – and often the same as – those used by the labs a doctor’s office uses,” said Liz Kwo, MD, chief medical officer at Everly Health. “Our at-home sample collection methods, like dried blood spots and saliva, have been widely used for decades.”
Home collection kits appeal to Uxmal Caldera, 27, of Miami Beach, who prefers to test in the privacy of his home. Mr. Caldera, who doesn’t have a car, said home testing saves him the time and expense of getting to a clinic.
Mr. Caldera has been testing himself for HIV and other STDs every 3 months for more than a year, part of routine monitoring for people taking PrEP, a regimen of daily pills to prevent HIV infection.
“Doing it by yourself is not hard at all,” said Mr. Caldera, who is uninsured but receives the tests free through a community foundation. “The instructions are really clear. I get the results in maybe 4 days. For sure, I would recommend it to other people.”
Leandro Mena, MD, director of the CDC’s division of STD prevention, said he would like to see at-home STD testing become as routine as home pregnancy tests. An estimated 16 million–20 million tests for gonorrhea and chlamydia are performed in the United States each year, Dr. Mena said. Widespread use of at-home STD testing could double or triple that number.
He noted that doctors have years of experience using home collection kits.
The Johns Hopkins Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases has distributed roughly 23,000 at-home STD kits since 2004, said Charlotte Gaydos, DrPH, a principal investigator with the center. The FDA generally allows such use if it’s part of research overseen by medical professionals. The center’s tests are now used by the Alaska health department, as well as Native American tribes in Arizona and Oklahoma.
Dr. Gaydos has published dozens of studies establishing that home collection kits for diseases such as chlamydia and gonorrhea are accurate and easy to use.
“There’s a huge amount of data showing that home testing works,” said Dr. Gaydos.
But Dr. Gaydos noted that her studies have been limited to small sample sizes. She said she doesn’t have the millions of dollars in funding it would take to run the sort of comprehensive trial the FDA typically requires for approval.
Jenny Mahn, director of clinical and sexual health at the National Coalition of STD Directors, said many public health labs are reluctant to handle home kits. “The public health labs won’t touch it without FDA’s blessing.”
Public health clinics often provide STD testing at little to no cost, while health insurance typically covers in-person testing at a private practice. But most consumers pay out-of-pocket for direct-to-consumer kits. Commercial pricing puts them out of reach for many people, particularly teens and young adults, who account for nearly half of STDs.
Adalja said the FDA has a history of moving slowly on home testing. The agency spent 7 years evaluating the first home HIV test it approved, which hit the market in 2012.
“Home testing is the way of the future,” said Laura Lindberg, PhD, a professor of public health at Rutgers University, Piscataway, N.J. “The pandemic opened the door to testing and treatment at home without traveling to a health care provider, and we aren’t going to be able to put the genie back in the bottle.”
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.
A hormone that can predict male long-term health
Insulin-like peptide 3 (INSL3) is a constitutive hormone secreted in men by the mature Leydig cells of the testes, explained the authors of the new study, published in Frontiers in Endocrinology.
“It is an accurate biomarker for Leydig cell functional capacity, reflecting their total cell number and differentiation status,” they said.
“The holy grail of aging research is to reduce the fitness gap that appears as people age,” said Ravinder Anand-Ivell, PhD, associate professor in endocrinology and reproductive physiology at the University of Nottingham (England), and study coauthor. Understanding why some people are more likely to develop disability and disease as they age is “vital” so that interventions can be found to ensure people not only live a long life but also a healthy life as they age, she highlighted.
The European team of researchers, led by scientists from the University of Nottingham, set out to determine the ability of INSL3 as a biomarker to predict hypogonadism and age-related morbidity, and whether this also allowed it to predict morbidity in a similar way to testosterone.
For the study, the researchers analyzed blood samples from the European Male Aging Study (EMAS) cohort to assess circulating INSL3 and its cross-sectional and longitudinal relationships to hypogonadism – defined by testosterone less than 10.5 nmol/L – and a range of age-related morbidities determined by correlation and regression analysis.
The EMAS cohort of community-dwelling men comprises more than 3,000 men, aged 40-79 years at the time of recruitment, from eight centers in Europe. Men were recruited from 2003 to 2004 and again 4-5 years later for a second phase of the study. In both phases, blood was collected for hormonal measurements, and subjects were assessed for anthropometric parameters and asked to complete questionnaires relating to their health, lifestyle, and diet.
Hormone levels remain constant
The results showed that, unlike testosterone, which fluctuates throughout a man’s life, INSL3 remains consistent, with the level at puberty remaining largely the same throughout a man’s life, decreasing only slightly into old age. “This makes it the first clear and reliable predictive biomarker of age-related morbidity as compared with any other measurable parameters,” explained the researchers.
They also discovered that the level of INSL3 in blood “correlates with a range of age-related conditions,” such as bone weakness, sexual dysfunction, diabetes, and cardiovascular disease.
They emphasized that the discovery of the consistent nature of this hormone is “very significant.” It means that a man with high INSL3 when young will still have high INSL3 when he is older, but someone with low INSL3 already at a young age will have low INSL3 when older, “making him more likely to acquire typical age-related illnesses.”
Dr. Anand-Ivell commented that the hormone discovery was an “important step” and will pave the way for not only helping people individually but also helping to “ease the care crisis we face as a society.”
Exciting possibilities for predicting age
The study also showed that the normal male population, even when young and relatively healthy, still shows an almost 10-fold variation between individuals in the concentration of INSL3 in the blood, the authors reported.
The authors highlighted that the study’s strengths are the large and comprehensive dataset provided by the EMAS cohort, together with the accuracy of the hormonal parameters measured. The weaknesses, they explained, are the self-reported nature of some of the morbidity parameters as well as the relatively short longitudinal dimension of only 4.3 years average.
Richard Ivell, University of Nottingham, and lead author, explained that now the important role of INSL3 in predicting disease, and how it varies amongst men, had been established, the team is looking to investigate what factors have the most influence on the level of INSL3 in the blood. “Preliminary work suggests early life nutrition may play a role, but many other factors such as genetics or exposure to some environmental endocrine disruptors may play a part”.
The study findings open up “exciting possibilities for predicting age-related illnesses and finding ways to prevent the onset of these diseases with early intervention,” the authors enthused.
The study was initiated and supported by the European 5th Framework, and the German Research Council provided funding for the INSL3 analysis. The authors declared no conflicts of interest.
Dr. Hicks has disclosed no relevant financial relationships. A version of this article first appeared on MedscapeUK.
Insulin-like peptide 3 (INSL3) is a constitutive hormone secreted in men by the mature Leydig cells of the testes, explained the authors of the new study, published in Frontiers in Endocrinology.
“It is an accurate biomarker for Leydig cell functional capacity, reflecting their total cell number and differentiation status,” they said.
“The holy grail of aging research is to reduce the fitness gap that appears as people age,” said Ravinder Anand-Ivell, PhD, associate professor in endocrinology and reproductive physiology at the University of Nottingham (England), and study coauthor. Understanding why some people are more likely to develop disability and disease as they age is “vital” so that interventions can be found to ensure people not only live a long life but also a healthy life as they age, she highlighted.
The European team of researchers, led by scientists from the University of Nottingham, set out to determine the ability of INSL3 as a biomarker to predict hypogonadism and age-related morbidity, and whether this also allowed it to predict morbidity in a similar way to testosterone.
For the study, the researchers analyzed blood samples from the European Male Aging Study (EMAS) cohort to assess circulating INSL3 and its cross-sectional and longitudinal relationships to hypogonadism – defined by testosterone less than 10.5 nmol/L – and a range of age-related morbidities determined by correlation and regression analysis.
The EMAS cohort of community-dwelling men comprises more than 3,000 men, aged 40-79 years at the time of recruitment, from eight centers in Europe. Men were recruited from 2003 to 2004 and again 4-5 years later for a second phase of the study. In both phases, blood was collected for hormonal measurements, and subjects were assessed for anthropometric parameters and asked to complete questionnaires relating to their health, lifestyle, and diet.
Hormone levels remain constant
The results showed that, unlike testosterone, which fluctuates throughout a man’s life, INSL3 remains consistent, with the level at puberty remaining largely the same throughout a man’s life, decreasing only slightly into old age. “This makes it the first clear and reliable predictive biomarker of age-related morbidity as compared with any other measurable parameters,” explained the researchers.
They also discovered that the level of INSL3 in blood “correlates with a range of age-related conditions,” such as bone weakness, sexual dysfunction, diabetes, and cardiovascular disease.
They emphasized that the discovery of the consistent nature of this hormone is “very significant.” It means that a man with high INSL3 when young will still have high INSL3 when he is older, but someone with low INSL3 already at a young age will have low INSL3 when older, “making him more likely to acquire typical age-related illnesses.”
Dr. Anand-Ivell commented that the hormone discovery was an “important step” and will pave the way for not only helping people individually but also helping to “ease the care crisis we face as a society.”
Exciting possibilities for predicting age
The study also showed that the normal male population, even when young and relatively healthy, still shows an almost 10-fold variation between individuals in the concentration of INSL3 in the blood, the authors reported.
The authors highlighted that the study’s strengths are the large and comprehensive dataset provided by the EMAS cohort, together with the accuracy of the hormonal parameters measured. The weaknesses, they explained, are the self-reported nature of some of the morbidity parameters as well as the relatively short longitudinal dimension of only 4.3 years average.
Richard Ivell, University of Nottingham, and lead author, explained that now the important role of INSL3 in predicting disease, and how it varies amongst men, had been established, the team is looking to investigate what factors have the most influence on the level of INSL3 in the blood. “Preliminary work suggests early life nutrition may play a role, but many other factors such as genetics or exposure to some environmental endocrine disruptors may play a part”.
The study findings open up “exciting possibilities for predicting age-related illnesses and finding ways to prevent the onset of these diseases with early intervention,” the authors enthused.
The study was initiated and supported by the European 5th Framework, and the German Research Council provided funding for the INSL3 analysis. The authors declared no conflicts of interest.
Dr. Hicks has disclosed no relevant financial relationships. A version of this article first appeared on MedscapeUK.
Insulin-like peptide 3 (INSL3) is a constitutive hormone secreted in men by the mature Leydig cells of the testes, explained the authors of the new study, published in Frontiers in Endocrinology.
“It is an accurate biomarker for Leydig cell functional capacity, reflecting their total cell number and differentiation status,” they said.
“The holy grail of aging research is to reduce the fitness gap that appears as people age,” said Ravinder Anand-Ivell, PhD, associate professor in endocrinology and reproductive physiology at the University of Nottingham (England), and study coauthor. Understanding why some people are more likely to develop disability and disease as they age is “vital” so that interventions can be found to ensure people not only live a long life but also a healthy life as they age, she highlighted.
The European team of researchers, led by scientists from the University of Nottingham, set out to determine the ability of INSL3 as a biomarker to predict hypogonadism and age-related morbidity, and whether this also allowed it to predict morbidity in a similar way to testosterone.
For the study, the researchers analyzed blood samples from the European Male Aging Study (EMAS) cohort to assess circulating INSL3 and its cross-sectional and longitudinal relationships to hypogonadism – defined by testosterone less than 10.5 nmol/L – and a range of age-related morbidities determined by correlation and regression analysis.
The EMAS cohort of community-dwelling men comprises more than 3,000 men, aged 40-79 years at the time of recruitment, from eight centers in Europe. Men were recruited from 2003 to 2004 and again 4-5 years later for a second phase of the study. In both phases, blood was collected for hormonal measurements, and subjects were assessed for anthropometric parameters and asked to complete questionnaires relating to their health, lifestyle, and diet.
Hormone levels remain constant
The results showed that, unlike testosterone, which fluctuates throughout a man’s life, INSL3 remains consistent, with the level at puberty remaining largely the same throughout a man’s life, decreasing only slightly into old age. “This makes it the first clear and reliable predictive biomarker of age-related morbidity as compared with any other measurable parameters,” explained the researchers.
They also discovered that the level of INSL3 in blood “correlates with a range of age-related conditions,” such as bone weakness, sexual dysfunction, diabetes, and cardiovascular disease.
They emphasized that the discovery of the consistent nature of this hormone is “very significant.” It means that a man with high INSL3 when young will still have high INSL3 when he is older, but someone with low INSL3 already at a young age will have low INSL3 when older, “making him more likely to acquire typical age-related illnesses.”
Dr. Anand-Ivell commented that the hormone discovery was an “important step” and will pave the way for not only helping people individually but also helping to “ease the care crisis we face as a society.”
Exciting possibilities for predicting age
The study also showed that the normal male population, even when young and relatively healthy, still shows an almost 10-fold variation between individuals in the concentration of INSL3 in the blood, the authors reported.
The authors highlighted that the study’s strengths are the large and comprehensive dataset provided by the EMAS cohort, together with the accuracy of the hormonal parameters measured. The weaknesses, they explained, are the self-reported nature of some of the morbidity parameters as well as the relatively short longitudinal dimension of only 4.3 years average.
Richard Ivell, University of Nottingham, and lead author, explained that now the important role of INSL3 in predicting disease, and how it varies amongst men, had been established, the team is looking to investigate what factors have the most influence on the level of INSL3 in the blood. “Preliminary work suggests early life nutrition may play a role, but many other factors such as genetics or exposure to some environmental endocrine disruptors may play a part”.
The study findings open up “exciting possibilities for predicting age-related illnesses and finding ways to prevent the onset of these diseases with early intervention,” the authors enthused.
The study was initiated and supported by the European 5th Framework, and the German Research Council provided funding for the INSL3 analysis. The authors declared no conflicts of interest.
Dr. Hicks has disclosed no relevant financial relationships. A version of this article first appeared on MedscapeUK.
FROM FRONTIERS IN ENDOCRINOLOGY
Doc trains family physicians in vasectomy care
One physician has made it his mission to help.
Charles W. Monteith Jr., MD, medical director of his own practice in Raleigh, N.C., said that before the Court’s decision in Dobbs v. Jackson , he was booked “2-3 weeks” in advance for vasectomies.
“Now I am booked out 3 months,” he said.
In September, Dr. Monteith launched a training program for physicians interested in providing vasectomies in their offices. The course, which Dr. Monteith conceived in 2021 before the Supreme Court’s latest ruling, offers one-on-one training and mentorship for physicians who want to learn to perform minimally invasive vasectomies under local anesthesia.
In addition to training, Dr. Monteith provides all the necessary equipment, including eye loupes, exam room surgical furniture, and instrument sterilization system. The program can be completed over 4 weekends and costs $38,000; participants typically perform 40 vasectomy procedures during the training period.
Dr. Monteith, who trained in obstetrics and gynecology, said that he has performed over 7,000 no-scalpel vasectomies since 2008.
Requests for vasectomy consultations at the end of June – when the Dobbs decision was announced – came from men of all ages but particularly from younger men with fewer than two children, Dr. Monteith said.
Prior to the ruling, men with no children accounted for 10% of his patient roster; now, he added, “some days, it is 80%.”
With the increase in demand came a unique opportunity for more doctors to offer the service. The majority of vasectomies in the United States, around 75%, are performed by urologists, but 25% are performed by specialists in family medicine or general surgery.
Some research shows that urologists are typically unwilling to train family physicians on the procedure, citing concerns over competition and not enough cases to go around. But Doug Stein, MD, a urologist and director of Vasectomy and Reversal Centers of Florida in Tampa, offers a similar training for physicians, most of whom are family physicians. Opening the door for more men to get a vasectomy may be a net good, according to Dr. Stein.
“There’s a lot of trust required for vasectomy,” Dr. Stein noted. “Men are probably more likely to go to their family medicine doctor,” that they have a rapport with than a specialist they’ve never met.
Alex Shteynshlyuger, MD, director of urology at New York Urology Specialists, said that he supports family physicians performing vasectomies. However, he cautioned that like any other procedure, complications can arise, and thorough training is essential.
“While complications are not common, they do occur, including pain, bleeding, infection, granuloma formation, and fistula tract,” Dr. Shteynshlyuger said. Family physicians must also know when to refer patients to a specialist.
Dr. Monteith said that safety considerations are why he designed his training program for clinicians who want to offer 10-20 vasectomies per week.
Dr. Monteith sees his work in teaching family care physicians on how to perform vasectomies similar to his previous role as medical director of Planned Parenthood of Central North Carolina. There, he helped provide family planning options, mostly to women. Now, he offers the options to men.
“Most of our public health efforts seem to be focused on female reproduction,” Dr. Monteith said. “It is never a good idea to let specialists be the main providers of a preventive healthcare treatment or service, kind of like only allowing patients to go to a cardiologist to get a prescription for cholesterol medication. I needed to do what I could do to increase the number of providers offering easier access to vasectomy.”
A version of this article first appeared on Medscape.com.
One physician has made it his mission to help.
Charles W. Monteith Jr., MD, medical director of his own practice in Raleigh, N.C., said that before the Court’s decision in Dobbs v. Jackson , he was booked “2-3 weeks” in advance for vasectomies.
“Now I am booked out 3 months,” he said.
In September, Dr. Monteith launched a training program for physicians interested in providing vasectomies in their offices. The course, which Dr. Monteith conceived in 2021 before the Supreme Court’s latest ruling, offers one-on-one training and mentorship for physicians who want to learn to perform minimally invasive vasectomies under local anesthesia.
In addition to training, Dr. Monteith provides all the necessary equipment, including eye loupes, exam room surgical furniture, and instrument sterilization system. The program can be completed over 4 weekends and costs $38,000; participants typically perform 40 vasectomy procedures during the training period.
Dr. Monteith, who trained in obstetrics and gynecology, said that he has performed over 7,000 no-scalpel vasectomies since 2008.
Requests for vasectomy consultations at the end of June – when the Dobbs decision was announced – came from men of all ages but particularly from younger men with fewer than two children, Dr. Monteith said.
Prior to the ruling, men with no children accounted for 10% of his patient roster; now, he added, “some days, it is 80%.”
With the increase in demand came a unique opportunity for more doctors to offer the service. The majority of vasectomies in the United States, around 75%, are performed by urologists, but 25% are performed by specialists in family medicine or general surgery.
Some research shows that urologists are typically unwilling to train family physicians on the procedure, citing concerns over competition and not enough cases to go around. But Doug Stein, MD, a urologist and director of Vasectomy and Reversal Centers of Florida in Tampa, offers a similar training for physicians, most of whom are family physicians. Opening the door for more men to get a vasectomy may be a net good, according to Dr. Stein.
“There’s a lot of trust required for vasectomy,” Dr. Stein noted. “Men are probably more likely to go to their family medicine doctor,” that they have a rapport with than a specialist they’ve never met.
Alex Shteynshlyuger, MD, director of urology at New York Urology Specialists, said that he supports family physicians performing vasectomies. However, he cautioned that like any other procedure, complications can arise, and thorough training is essential.
“While complications are not common, they do occur, including pain, bleeding, infection, granuloma formation, and fistula tract,” Dr. Shteynshlyuger said. Family physicians must also know when to refer patients to a specialist.
Dr. Monteith said that safety considerations are why he designed his training program for clinicians who want to offer 10-20 vasectomies per week.
Dr. Monteith sees his work in teaching family care physicians on how to perform vasectomies similar to his previous role as medical director of Planned Parenthood of Central North Carolina. There, he helped provide family planning options, mostly to women. Now, he offers the options to men.
“Most of our public health efforts seem to be focused on female reproduction,” Dr. Monteith said. “It is never a good idea to let specialists be the main providers of a preventive healthcare treatment or service, kind of like only allowing patients to go to a cardiologist to get a prescription for cholesterol medication. I needed to do what I could do to increase the number of providers offering easier access to vasectomy.”
A version of this article first appeared on Medscape.com.
One physician has made it his mission to help.
Charles W. Monteith Jr., MD, medical director of his own practice in Raleigh, N.C., said that before the Court’s decision in Dobbs v. Jackson , he was booked “2-3 weeks” in advance for vasectomies.
“Now I am booked out 3 months,” he said.
In September, Dr. Monteith launched a training program for physicians interested in providing vasectomies in their offices. The course, which Dr. Monteith conceived in 2021 before the Supreme Court’s latest ruling, offers one-on-one training and mentorship for physicians who want to learn to perform minimally invasive vasectomies under local anesthesia.
In addition to training, Dr. Monteith provides all the necessary equipment, including eye loupes, exam room surgical furniture, and instrument sterilization system. The program can be completed over 4 weekends and costs $38,000; participants typically perform 40 vasectomy procedures during the training period.
Dr. Monteith, who trained in obstetrics and gynecology, said that he has performed over 7,000 no-scalpel vasectomies since 2008.
Requests for vasectomy consultations at the end of June – when the Dobbs decision was announced – came from men of all ages but particularly from younger men with fewer than two children, Dr. Monteith said.
Prior to the ruling, men with no children accounted for 10% of his patient roster; now, he added, “some days, it is 80%.”
With the increase in demand came a unique opportunity for more doctors to offer the service. The majority of vasectomies in the United States, around 75%, are performed by urologists, but 25% are performed by specialists in family medicine or general surgery.
Some research shows that urologists are typically unwilling to train family physicians on the procedure, citing concerns over competition and not enough cases to go around. But Doug Stein, MD, a urologist and director of Vasectomy and Reversal Centers of Florida in Tampa, offers a similar training for physicians, most of whom are family physicians. Opening the door for more men to get a vasectomy may be a net good, according to Dr. Stein.
“There’s a lot of trust required for vasectomy,” Dr. Stein noted. “Men are probably more likely to go to their family medicine doctor,” that they have a rapport with than a specialist they’ve never met.
Alex Shteynshlyuger, MD, director of urology at New York Urology Specialists, said that he supports family physicians performing vasectomies. However, he cautioned that like any other procedure, complications can arise, and thorough training is essential.
“While complications are not common, they do occur, including pain, bleeding, infection, granuloma formation, and fistula tract,” Dr. Shteynshlyuger said. Family physicians must also know when to refer patients to a specialist.
Dr. Monteith said that safety considerations are why he designed his training program for clinicians who want to offer 10-20 vasectomies per week.
Dr. Monteith sees his work in teaching family care physicians on how to perform vasectomies similar to his previous role as medical director of Planned Parenthood of Central North Carolina. There, he helped provide family planning options, mostly to women. Now, he offers the options to men.
“Most of our public health efforts seem to be focused on female reproduction,” Dr. Monteith said. “It is never a good idea to let specialists be the main providers of a preventive healthcare treatment or service, kind of like only allowing patients to go to a cardiologist to get a prescription for cholesterol medication. I needed to do what I could do to increase the number of providers offering easier access to vasectomy.”
A version of this article first appeared on Medscape.com.
Testosterone ranges for young men could help classify deficiency
Normative ranges of testosterone in young men have been identified on the basis of a nationally representative data in a new study, and these data are expected to provide guidance when evaluating younger individuals presenting with signs and symptoms of potential testosterone deficiency, according to the investigators.
It has long been known that the ranges of normal testosterone differ by age, but the authors of this study contend that this is the first large-scale, population-based analysis conducted in the United States of testosterone levels among in men aged 20-44 years.
“These findings will provide valuable information that clinicians can use in the evaluation and management of young men presenting with concerns about testosterone deficiency,” reported a team of investigators led by Alex Zhu, MD, a urology resident at the University of Michigan, Ann Arbor, in the Journal of Urology.
Outside experts, however, disagree, one saying that the conclusions are “far off and irrational.”
A normative range of testosterone is particularly important for the evaluation of hypogonadism because values vary markedly between individuals and within individuals on repeat measurements over a 24-hour period. At least partially because of this variability, many guidelines, including those issued in by the Endocrine Society and the American Urological Association, recommend testosterone assays only in symptomatic individuals in order to reduce risk of detecting low relative levels that are not clinically relevant.
NHANES data provide norms
The data for this study were drawn from the National Health and Nutrition Examination Surveys (NHANES), which sample representative United States residents. The analytic cohort included 1,486 men stratified in 5-year age intervals (20-24, 25-29, 30-34, 35-39, and 40-44).
Because of the known diurnal variation in endocrine levels, only morning total testosterone levels were considered, for consistency. Individuals at risk of disturbed testosterone levels, such as those on hormonal therapy or with a history of testicular cancer, were excluded. Unlike previous analyses that have limited measurements to nonobese individuals without major comorbidities, no such restrictions were imposed in this analysis, which included a sample balanced by race.
After dividing the testosterone levels collected in the NHANES data by tertiles, the cutoff for reduced testosterone were defined as the lowest tertile for each of the five age groups studied.
Consistent with previous reports that testosterone levels decline with age, the cutoff for low testosterone declined for each increase in 5-year age interval after the age of 29 years.
Specifically, these cutoffs were, in order of advancing age, 409 ng/dL (middle tertile range, 409-558), 413 ng/dL (range, 413-575), 359 ng/dL (range, 359-498), 352 ng/dL (range, 352-478), and 350 ng/dL (range, 350-473).
As in the AUA guidelines, which define a total testosterone level below 300 ng/dL “as a reasonable cutoff in support of the diagnosis of low testosterone,” these cutoffs were established without correlation with symptoms. In younger men, like older men, testosterone levels must be within a clinical context.
“Per the AUA guidelines, clinician should consider measuring testosterone levels in patients with certain medical conditions or signs or symptoms of testosterone deficiency, such as depression, reduced motivation, infertility, reduced sex drive, and changes in erectile function,” Dr. Zhu said in an interview, adding that it is appropriate to follow the AUA guidelines “regardless of age.”
Hormone levels and symptoms not correlated
These recommendations are based on the fact that the correlation between symptomatic hypogonadism and testosterone levels is poor, meaning that other factors should be considered when considering whether symptoms relate to deficiency. However, Dr. Zhu contended that objective evidence of a low level of testosterone is useful in considering the role of hormone deficiency.
“Even if one were to choose a different cutoff, our age-specific normative testosterone ranges still provide young men and their physicians a framework for counseling,” according to Dr. Zhu. Because of the risk of nonspecific symptoms, such as fatigue and diminished physical performance, he called for “a high index of suspicion for testosterone deficiency even when evaluating younger men.”
Considering the diurnal fluctuations, the single measurement employed to calculate normative ranges is a limitation of this study, the authors acknowledged. They cited data suggested that up to 35% of men classified as hypogonadal on the basis of a single testosterone assay will not meet the same criterion even if evaluated in the subsequent 24 hours. It is for this reason that guidelines typically recommend measuring testosterone at least twice or with more than one type of assay.
Up until now, decisions about testosterone deficiency have been with a one-size-fits-all approach, but it has long been known that patient age is a variable in determining average levels of this hormone, Dr. Zhu reported. For this reason, he predicted that these data will have clinical utility.
“We believe that our new cutoffs play an important role in evaluating younger men presenting with symptoms [of testosterone deficiency],” Dr. Zhu said. “However, clinicians should still remember that these symptoms have causes other than low testosterone, so we cannot only focus only on testing testosterone.”
However, given the lack of correlation between symptoms and testosterone levels, this area remains controversial.
Value of tertile cutoffs questioned
Two independent experts challenged the methodology and conclusions of this study.
Victor Adlin, MD, an associate professor emeritus at Temple University, Philadelphia, questioned tertile levels as an approach to defining normal.
“The authors propose unusually high cut-points for a definition of low testosterone in young men,” said Dr. Adlin, whose published a comment on age-related low testosterone in response to 2020 guidelines issued by the American College of Physicians. He is concerned that these data could lead to overtreatment.
The authors “imply that [these data] would justify treatment with testosterone in many young men with symptoms such as fatigue, depression, and lack of vigor, whose relation to low testosterone is controversial,” he said in an interview. “Trials in older men have failed to show a clear response of such symptoms to testosterone therapy.”
The first author of the 2018 Endocrine Society guidelines, Shalender Bhasin, MB, BS, director of a research program in aging and metabolism at the Brigham and Women’s Hospital in Boston, was even more skeptical.
“The whole premise of generating cutoffs for a disease or condition based on the middle tertile is just so far off and irrational,” he said. A coauthor of a 2017 study designed to define harmonized testosterone reference ranges by decade of age (that he described as providing “a much larger sample size and a wider age range” than this current study), Dr. Bhasin did not see any value in the NHANES-based analysis.
Rather, he called for an effort “to dispel this ill-conceived idea that could mislead young men to think they need testosterone treatment when they are healthy.”
Dr. Zhu and Dr. Adlin reported no potential conflicts of interest. Dr. Bhasin reported financial relationships with AbbVie, Eli Lilly, Novartis, Regeneron, and Takeda.
Normative ranges of testosterone in young men have been identified on the basis of a nationally representative data in a new study, and these data are expected to provide guidance when evaluating younger individuals presenting with signs and symptoms of potential testosterone deficiency, according to the investigators.
It has long been known that the ranges of normal testosterone differ by age, but the authors of this study contend that this is the first large-scale, population-based analysis conducted in the United States of testosterone levels among in men aged 20-44 years.
“These findings will provide valuable information that clinicians can use in the evaluation and management of young men presenting with concerns about testosterone deficiency,” reported a team of investigators led by Alex Zhu, MD, a urology resident at the University of Michigan, Ann Arbor, in the Journal of Urology.
Outside experts, however, disagree, one saying that the conclusions are “far off and irrational.”
A normative range of testosterone is particularly important for the evaluation of hypogonadism because values vary markedly between individuals and within individuals on repeat measurements over a 24-hour period. At least partially because of this variability, many guidelines, including those issued in by the Endocrine Society and the American Urological Association, recommend testosterone assays only in symptomatic individuals in order to reduce risk of detecting low relative levels that are not clinically relevant.
NHANES data provide norms
The data for this study were drawn from the National Health and Nutrition Examination Surveys (NHANES), which sample representative United States residents. The analytic cohort included 1,486 men stratified in 5-year age intervals (20-24, 25-29, 30-34, 35-39, and 40-44).
Because of the known diurnal variation in endocrine levels, only morning total testosterone levels were considered, for consistency. Individuals at risk of disturbed testosterone levels, such as those on hormonal therapy or with a history of testicular cancer, were excluded. Unlike previous analyses that have limited measurements to nonobese individuals without major comorbidities, no such restrictions were imposed in this analysis, which included a sample balanced by race.
After dividing the testosterone levels collected in the NHANES data by tertiles, the cutoff for reduced testosterone were defined as the lowest tertile for each of the five age groups studied.
Consistent with previous reports that testosterone levels decline with age, the cutoff for low testosterone declined for each increase in 5-year age interval after the age of 29 years.
Specifically, these cutoffs were, in order of advancing age, 409 ng/dL (middle tertile range, 409-558), 413 ng/dL (range, 413-575), 359 ng/dL (range, 359-498), 352 ng/dL (range, 352-478), and 350 ng/dL (range, 350-473).
As in the AUA guidelines, which define a total testosterone level below 300 ng/dL “as a reasonable cutoff in support of the diagnosis of low testosterone,” these cutoffs were established without correlation with symptoms. In younger men, like older men, testosterone levels must be within a clinical context.
“Per the AUA guidelines, clinician should consider measuring testosterone levels in patients with certain medical conditions or signs or symptoms of testosterone deficiency, such as depression, reduced motivation, infertility, reduced sex drive, and changes in erectile function,” Dr. Zhu said in an interview, adding that it is appropriate to follow the AUA guidelines “regardless of age.”
Hormone levels and symptoms not correlated
These recommendations are based on the fact that the correlation between symptomatic hypogonadism and testosterone levels is poor, meaning that other factors should be considered when considering whether symptoms relate to deficiency. However, Dr. Zhu contended that objective evidence of a low level of testosterone is useful in considering the role of hormone deficiency.
“Even if one were to choose a different cutoff, our age-specific normative testosterone ranges still provide young men and their physicians a framework for counseling,” according to Dr. Zhu. Because of the risk of nonspecific symptoms, such as fatigue and diminished physical performance, he called for “a high index of suspicion for testosterone deficiency even when evaluating younger men.”
Considering the diurnal fluctuations, the single measurement employed to calculate normative ranges is a limitation of this study, the authors acknowledged. They cited data suggested that up to 35% of men classified as hypogonadal on the basis of a single testosterone assay will not meet the same criterion even if evaluated in the subsequent 24 hours. It is for this reason that guidelines typically recommend measuring testosterone at least twice or with more than one type of assay.
Up until now, decisions about testosterone deficiency have been with a one-size-fits-all approach, but it has long been known that patient age is a variable in determining average levels of this hormone, Dr. Zhu reported. For this reason, he predicted that these data will have clinical utility.
“We believe that our new cutoffs play an important role in evaluating younger men presenting with symptoms [of testosterone deficiency],” Dr. Zhu said. “However, clinicians should still remember that these symptoms have causes other than low testosterone, so we cannot only focus only on testing testosterone.”
However, given the lack of correlation between symptoms and testosterone levels, this area remains controversial.
Value of tertile cutoffs questioned
Two independent experts challenged the methodology and conclusions of this study.
Victor Adlin, MD, an associate professor emeritus at Temple University, Philadelphia, questioned tertile levels as an approach to defining normal.
“The authors propose unusually high cut-points for a definition of low testosterone in young men,” said Dr. Adlin, whose published a comment on age-related low testosterone in response to 2020 guidelines issued by the American College of Physicians. He is concerned that these data could lead to overtreatment.
The authors “imply that [these data] would justify treatment with testosterone in many young men with symptoms such as fatigue, depression, and lack of vigor, whose relation to low testosterone is controversial,” he said in an interview. “Trials in older men have failed to show a clear response of such symptoms to testosterone therapy.”
The first author of the 2018 Endocrine Society guidelines, Shalender Bhasin, MB, BS, director of a research program in aging and metabolism at the Brigham and Women’s Hospital in Boston, was even more skeptical.
“The whole premise of generating cutoffs for a disease or condition based on the middle tertile is just so far off and irrational,” he said. A coauthor of a 2017 study designed to define harmonized testosterone reference ranges by decade of age (that he described as providing “a much larger sample size and a wider age range” than this current study), Dr. Bhasin did not see any value in the NHANES-based analysis.
Rather, he called for an effort “to dispel this ill-conceived idea that could mislead young men to think they need testosterone treatment when they are healthy.”
Dr. Zhu and Dr. Adlin reported no potential conflicts of interest. Dr. Bhasin reported financial relationships with AbbVie, Eli Lilly, Novartis, Regeneron, and Takeda.
Normative ranges of testosterone in young men have been identified on the basis of a nationally representative data in a new study, and these data are expected to provide guidance when evaluating younger individuals presenting with signs and symptoms of potential testosterone deficiency, according to the investigators.
It has long been known that the ranges of normal testosterone differ by age, but the authors of this study contend that this is the first large-scale, population-based analysis conducted in the United States of testosterone levels among in men aged 20-44 years.
“These findings will provide valuable information that clinicians can use in the evaluation and management of young men presenting with concerns about testosterone deficiency,” reported a team of investigators led by Alex Zhu, MD, a urology resident at the University of Michigan, Ann Arbor, in the Journal of Urology.
Outside experts, however, disagree, one saying that the conclusions are “far off and irrational.”
A normative range of testosterone is particularly important for the evaluation of hypogonadism because values vary markedly between individuals and within individuals on repeat measurements over a 24-hour period. At least partially because of this variability, many guidelines, including those issued in by the Endocrine Society and the American Urological Association, recommend testosterone assays only in symptomatic individuals in order to reduce risk of detecting low relative levels that are not clinically relevant.
NHANES data provide norms
The data for this study were drawn from the National Health and Nutrition Examination Surveys (NHANES), which sample representative United States residents. The analytic cohort included 1,486 men stratified in 5-year age intervals (20-24, 25-29, 30-34, 35-39, and 40-44).
Because of the known diurnal variation in endocrine levels, only morning total testosterone levels were considered, for consistency. Individuals at risk of disturbed testosterone levels, such as those on hormonal therapy or with a history of testicular cancer, were excluded. Unlike previous analyses that have limited measurements to nonobese individuals without major comorbidities, no such restrictions were imposed in this analysis, which included a sample balanced by race.
After dividing the testosterone levels collected in the NHANES data by tertiles, the cutoff for reduced testosterone were defined as the lowest tertile for each of the five age groups studied.
Consistent with previous reports that testosterone levels decline with age, the cutoff for low testosterone declined for each increase in 5-year age interval after the age of 29 years.
Specifically, these cutoffs were, in order of advancing age, 409 ng/dL (middle tertile range, 409-558), 413 ng/dL (range, 413-575), 359 ng/dL (range, 359-498), 352 ng/dL (range, 352-478), and 350 ng/dL (range, 350-473).
As in the AUA guidelines, which define a total testosterone level below 300 ng/dL “as a reasonable cutoff in support of the diagnosis of low testosterone,” these cutoffs were established without correlation with symptoms. In younger men, like older men, testosterone levels must be within a clinical context.
“Per the AUA guidelines, clinician should consider measuring testosterone levels in patients with certain medical conditions or signs or symptoms of testosterone deficiency, such as depression, reduced motivation, infertility, reduced sex drive, and changes in erectile function,” Dr. Zhu said in an interview, adding that it is appropriate to follow the AUA guidelines “regardless of age.”
Hormone levels and symptoms not correlated
These recommendations are based on the fact that the correlation between symptomatic hypogonadism and testosterone levels is poor, meaning that other factors should be considered when considering whether symptoms relate to deficiency. However, Dr. Zhu contended that objective evidence of a low level of testosterone is useful in considering the role of hormone deficiency.
“Even if one were to choose a different cutoff, our age-specific normative testosterone ranges still provide young men and their physicians a framework for counseling,” according to Dr. Zhu. Because of the risk of nonspecific symptoms, such as fatigue and diminished physical performance, he called for “a high index of suspicion for testosterone deficiency even when evaluating younger men.”
Considering the diurnal fluctuations, the single measurement employed to calculate normative ranges is a limitation of this study, the authors acknowledged. They cited data suggested that up to 35% of men classified as hypogonadal on the basis of a single testosterone assay will not meet the same criterion even if evaluated in the subsequent 24 hours. It is for this reason that guidelines typically recommend measuring testosterone at least twice or with more than one type of assay.
Up until now, decisions about testosterone deficiency have been with a one-size-fits-all approach, but it has long been known that patient age is a variable in determining average levels of this hormone, Dr. Zhu reported. For this reason, he predicted that these data will have clinical utility.
“We believe that our new cutoffs play an important role in evaluating younger men presenting with symptoms [of testosterone deficiency],” Dr. Zhu said. “However, clinicians should still remember that these symptoms have causes other than low testosterone, so we cannot only focus only on testing testosterone.”
However, given the lack of correlation between symptoms and testosterone levels, this area remains controversial.
Value of tertile cutoffs questioned
Two independent experts challenged the methodology and conclusions of this study.
Victor Adlin, MD, an associate professor emeritus at Temple University, Philadelphia, questioned tertile levels as an approach to defining normal.
“The authors propose unusually high cut-points for a definition of low testosterone in young men,” said Dr. Adlin, whose published a comment on age-related low testosterone in response to 2020 guidelines issued by the American College of Physicians. He is concerned that these data could lead to overtreatment.
The authors “imply that [these data] would justify treatment with testosterone in many young men with symptoms such as fatigue, depression, and lack of vigor, whose relation to low testosterone is controversial,” he said in an interview. “Trials in older men have failed to show a clear response of such symptoms to testosterone therapy.”
The first author of the 2018 Endocrine Society guidelines, Shalender Bhasin, MB, BS, director of a research program in aging and metabolism at the Brigham and Women’s Hospital in Boston, was even more skeptical.
“The whole premise of generating cutoffs for a disease or condition based on the middle tertile is just so far off and irrational,” he said. A coauthor of a 2017 study designed to define harmonized testosterone reference ranges by decade of age (that he described as providing “a much larger sample size and a wider age range” than this current study), Dr. Bhasin did not see any value in the NHANES-based analysis.
Rather, he called for an effort “to dispel this ill-conceived idea that could mislead young men to think they need testosterone treatment when they are healthy.”
Dr. Zhu and Dr. Adlin reported no potential conflicts of interest. Dr. Bhasin reported financial relationships with AbbVie, Eli Lilly, Novartis, Regeneron, and Takeda.
FROM THE JOURNAL OF UROLOGY