Rise of Testosterone Clinics Raises Concerns Over Side Effects and Safety - Martin Miner
October 29, 2024
Martin Miner discusses a Wall Street Journal article highlighting concerns about testosterone clinics and replacement therapy. Dr. Miner explains who makes appropriate candidates for testosterone therapy, emphasizing the importance of both low levels and clinical symptoms, while cautioning against the trend of younger men seeking treatment purely for body image concerns. He discusses how testosterone deficiency often accompanies metabolic syndrome and other conditions, including post-COVID effects. Dr. Miner addresses safety concerns, citing the TRAVERSE study's findings that proper testosterone replacement doesn't increase cardiovascular risks. The conversation highlights the distinction between legitimate medical treatment and profit-driven clinics charging premium prices for medications. He explores the relationship between testosterone, weight loss, and diabetes management, while emphasizing the need for comprehensive evaluation and appropriate patient selection rather than indiscriminate prescribing.
Biographies:
Martin Miner, MD, Co-Director, Lifespan Men’s Health Center, The Miriam Hospital, Providence, RI
E. David Crawford, MD, Urologist, Professor of Urology, Jack A. Vickers Director of Prostate Cancer Research, University of California San Diego, San Diego Health, San Diego, CA, The University of Colorado Anschutz Medical Campus, Aurora, CO
Biographies:
Martin Miner, MD, Co-Director, Lifespan Men’s Health Center, The Miriam Hospital, Providence, RI
E. David Crawford, MD, Urologist, Professor of Urology, Jack A. Vickers Director of Prostate Cancer Research, University of California San Diego, San Diego Health, San Diego, CA, The University of Colorado Anschutz Medical Campus, Aurora, CO
Read the Full Video Transcript
E. David Crawford: Hi everyone. My name is E. David Crawford, and I'm a professor of urology at the University of California in San Diego. Several days ago, I read on the front page of the Wall Street Journal an article entitled, "Testosterone Clinics Sell Virility. Some Men End Up With Infertility." Many men seeking a boost in the gym and in the bedroom learn too late about the possible side effects, including infertility and worse. There were a number of men that talked about this, endorsed it. Former presidential candidate Robert F. Kennedy Jr. We heard a little bit from Elon Musk and others. We know that there are some side effects from testosterone replacement therapy. They talked about those in the article and also that the number of prescriptions have gone from less than a hundred thousand to over a million a month in the last couple of years. Joining me to discuss this is somebody that I think is very capable of it.
His name is Marty Miner. Marty is a founder and an internist at the Lifespan Men's Health Center and former chair of the Department of Family Medicine at Miriam Hospital in Providence, Rhode Island. Marty was one of the first to start men's health clinics in the United States at Brown University. Interestingly, Marty graduated from the same medical school that I did, the University of Cincinnati. He has done so much in his career as a family practice doctor, but he's been very aligned with urology. He's president-elect of the Androgen Society. He's participated in so many AUA guideline committees: erectile dysfunction, Peyronie's disease, testosterone deficiency, and early screening for prostate cancer. He's former president of the American Society of Men's Health and published extensively in the disease. Marty, welcome. It's great to have you with us here in UroToday.
Martin Miner: Thank you, David.
E. David Crawford: I know you've had a chance to look at this article and just break it down and talk about it a little bit. But first of all, let's define who is a candidate for testosterone replacement therapy before we get into the side effects.
Martin Miner: So I see between 24 and 28 men a day who come to my office at the hospital and are there because their testosterone levels are low and they wonder whether they should be treated with testosterone therapy. And the genesis of testosterone deficiency, which is actually a clinical problem, a clinical syndrome defined by both the presence of low levels and clinical signs and symptoms, which include marked, debilitating fatigue, lethargy, loss of libido, loss of motivation, some impaired memory and perhaps cognitive dysfunction and erectile dysfunction and the loss of spontaneous erections. These men have often been suffering for a long period of time and have been worked up by their primary care clinicians for chronic fatigue syndrome or Lyme disease or other problems. And then they've suggested to their providers, "Let's draw a testosterone level," and lo and behold, it's found to be low and therefore sent to me.
I treat these men. The major cause of testosterone deficiency is the loss of the production of testosterone, either from the hypothalamic axis or the gonads, the testes themselves. And the reason that occurs is because of the most significant comorbidity of aging men, which is obesity. We see testosterone deficiency as one of the conditions that travels or traverses along with metabolic syndrome and along with hypertension and elevated lipids and type 2 diabetes, and it's all in that spectrum. So from our research, low levels of testosterone are associated with increased cardiovascular risk. We can't say that they cause increased cardiovascular risk, but they're strongly associated because of all the comorbidities that are associated with cardiovascular risk that seem to follow low testosterone levels. Another one more recently, of course, is COVID. We see low levels following COVID infection in men, in 25 to 50% of men following a COVID illness and for up to 12 months. So the men who should be treated are those who are symptomatic with persistently low levels.
This article pointed out that many men in their 30s and 40s who are feeling awkward about their body images or that they're just not strong enough are coming to these "T" clinics for testosterone supplementation, and they don't fit the criteria for traditional testosterone deficiency, meaning they don't have true low levels and they don't have the established clinical signs and symptoms of testosterone deficiency.
E. David Crawford: So Marty, let me just ask a question. I've always said that a lot of men have their thermostats set differently. There are men with testosterone of 300, have no symptoms, and somebody's 550 that does.
Martin Miner: Right, exactly. And that thermostat, David, which is responsible, now we know that it's called a metabolic set point. It establishes their weight, and they often can't get an improvement of that weight unless they use one of the newer weight loss medications like the GLP-1s. But those men, I see men who have very low levels and have no symptoms, and I might follow those men once a year or they know to come back to me if they become symptomatic. But I try to educate them as to what they can do lifestyle-wise to improve or raise their levels.
E. David Crawford: You were one of the first that years ago told me about the GLP-1 drugs and the Ozempics and things that were around that we're going to hear about this, about weight loss, and you were absolutely right. It's an epidemic of that going around. Does correcting the weight and weight loss improve testosterone in men, muscle mass?
Martin Miner: It certainly can improve. Correcting the weight, improving sleep, because many of these men have sleep disorders. And by the way, these clinics aren't really looking at any sleep issues on these men. They're not looking at mood issues, they're not looking at sleep. These are often manifestations of testosterone deficiency. It's a multifactorial issue and it's truly an art. And there are guidelines about the use of testosterone therapy just as there are guidelines about the use of the GLP-1 meds for weight loss.
E. David Crawford: You just said something about COVID, which I sort of knew, but is that—did patients recover from that? The low T that occur?
Martin Miner: They often do, but sometimes it takes between 12 and 15 months. And if they're really symptomatic, I will treat those men for a time to help them recover. And then we might do other things like use Clomiphene or human chorionic gonadotropin low dose to re-stimulate their testosterone recovery. But the issue of these clinics, what came out particularly negative is that these are more of financial mercenary clinics, which call themselves men's health centers but really aren't interested in health at all. They're interested in getting a group of individuals who are paying a monthly subscription fee between, I think, $1,200 and $2,600 a year, paying $100 to $200 a month for a medication that can be purchased at CVS or Walgreens for between $12 and $30.
E. David Crawford: With a prescription, though. Let's move on to the risk in the last couple minutes here. I know that the testosterone replacement therapy was sort of on the watch list with the FDA and concerns about restricting it. There was a study that you're very familiar with, involved with, called the TRAVERSE study.
Martin Miner: That's correct.
E. David Crawford: What was the take-home message from that study that changed all of this with testosterone and cardiovascular—
Martin Miner: The TRAVERSE study showed that there was no increase in cardiovascular endpoints, in cardiovascular events including heart attack and stroke, from the use of testosterone therapy in the form of a testosterone gel in up to 5,500 men for a median of about 33 months. Back in 2015, the growth of testosterone therapy, as pointed out by this article accurately, was quite significant. It was one of the fastest-growing drugs when the topical AndroGel was introduced by AbbVie. And because of that, the FDA was very concerned with a couple of cross-sectional studies, poorly done studies, but they did show an increase in heart attack and potential strokes. That is not the case. Testosterone does not appear to be associated with an increase in heart attacks and strokes. That's testosterone replacement.
However, the most commonly used testosterone are the injectables, and we haven't really studied those for safety with the same scrutiny as this long-term safety study. So I still am concerned about the polycythemia or the increase in hematocrits that we see with the use of testosterone therapy. There's no concern or little concern anymore about the relationship of testosterone causing prostate or breast cancer, which there originally was a significant amount, as you know prior.
E. David Crawford: That was always a significant fear. That sort of got me interested in TRT. Two more things here. One is diabetes. There's a study ongoing with that too, right, with testosterone replacement?
Martin Miner: The T4DM study, the large Australian study, which showed that testosterone therapy actually induced a remission together with lifestyle and exercise. So those two can't be ignored. Lifestyle and exercise together with testosterone therapy induced a remission of type 2 diabetes, and I think it was largely facilitated by the weight loss that accompanied the interventions. So the men that I see, David—and this gets back to your first question, who should be treated—the men that I see often have no motivation to exercise, and the only way to get them to exercise or to sleep better is to use testosterone. I look at it as a tool, which we can use anywhere from 12 to 24 months. Some men may be on it indeed indefinitely for a longer period of time, and I think it's generally safe, but it should not be given to men of this age group, which is the 30- to 40-year-old age group. And I don't give it to those men in my practice unless they clearly understand that it could impair fertility, which is one of the points of this article.
E. David Crawford: And then the withdrawal and things like that. Marty, it's great having you on.
Martin Miner: Yeah. It's always wonderful.
E. David Crawford: I think this article really was well written and it did bring forward the concerns about this, the widespread use of testosterone replacement. There's a lot of variables and we need experts like you and educated urologists and others and family practice doctors to properly diagnose and treat these men so we don't have this sort of problem. Thank you so much, Marty.
Martin Miner: Thank you, David.
E. David Crawford: We appreciate it.
Martin Miner: Yeah, anytime.
E. David Crawford: Hi everyone. My name is E. David Crawford, and I'm a professor of urology at the University of California in San Diego. Several days ago, I read on the front page of the Wall Street Journal an article entitled, "Testosterone Clinics Sell Virility. Some Men End Up With Infertility." Many men seeking a boost in the gym and in the bedroom learn too late about the possible side effects, including infertility and worse. There were a number of men that talked about this, endorsed it. Former presidential candidate Robert F. Kennedy Jr. We heard a little bit from Elon Musk and others. We know that there are some side effects from testosterone replacement therapy. They talked about those in the article and also that the number of prescriptions have gone from less than a hundred thousand to over a million a month in the last couple of years. Joining me to discuss this is somebody that I think is very capable of it.
His name is Marty Miner. Marty is a founder and an internist at the Lifespan Men's Health Center and former chair of the Department of Family Medicine at Miriam Hospital in Providence, Rhode Island. Marty was one of the first to start men's health clinics in the United States at Brown University. Interestingly, Marty graduated from the same medical school that I did, the University of Cincinnati. He has done so much in his career as a family practice doctor, but he's been very aligned with urology. He's president-elect of the Androgen Society. He's participated in so many AUA guideline committees: erectile dysfunction, Peyronie's disease, testosterone deficiency, and early screening for prostate cancer. He's former president of the American Society of Men's Health and published extensively in the disease. Marty, welcome. It's great to have you with us here in UroToday.
Martin Miner: Thank you, David.
E. David Crawford: I know you've had a chance to look at this article and just break it down and talk about it a little bit. But first of all, let's define who is a candidate for testosterone replacement therapy before we get into the side effects.
Martin Miner: So I see between 24 and 28 men a day who come to my office at the hospital and are there because their testosterone levels are low and they wonder whether they should be treated with testosterone therapy. And the genesis of testosterone deficiency, which is actually a clinical problem, a clinical syndrome defined by both the presence of low levels and clinical signs and symptoms, which include marked, debilitating fatigue, lethargy, loss of libido, loss of motivation, some impaired memory and perhaps cognitive dysfunction and erectile dysfunction and the loss of spontaneous erections. These men have often been suffering for a long period of time and have been worked up by their primary care clinicians for chronic fatigue syndrome or Lyme disease or other problems. And then they've suggested to their providers, "Let's draw a testosterone level," and lo and behold, it's found to be low and therefore sent to me.
I treat these men. The major cause of testosterone deficiency is the loss of the production of testosterone, either from the hypothalamic axis or the gonads, the testes themselves. And the reason that occurs is because of the most significant comorbidity of aging men, which is obesity. We see testosterone deficiency as one of the conditions that travels or traverses along with metabolic syndrome and along with hypertension and elevated lipids and type 2 diabetes, and it's all in that spectrum. So from our research, low levels of testosterone are associated with increased cardiovascular risk. We can't say that they cause increased cardiovascular risk, but they're strongly associated because of all the comorbidities that are associated with cardiovascular risk that seem to follow low testosterone levels. Another one more recently, of course, is COVID. We see low levels following COVID infection in men, in 25 to 50% of men following a COVID illness and for up to 12 months. So the men who should be treated are those who are symptomatic with persistently low levels.
This article pointed out that many men in their 30s and 40s who are feeling awkward about their body images or that they're just not strong enough are coming to these "T" clinics for testosterone supplementation, and they don't fit the criteria for traditional testosterone deficiency, meaning they don't have true low levels and they don't have the established clinical signs and symptoms of testosterone deficiency.
E. David Crawford: So Marty, let me just ask a question. I've always said that a lot of men have their thermostats set differently. There are men with testosterone of 300, have no symptoms, and somebody's 550 that does.
Martin Miner: Right, exactly. And that thermostat, David, which is responsible, now we know that it's called a metabolic set point. It establishes their weight, and they often can't get an improvement of that weight unless they use one of the newer weight loss medications like the GLP-1s. But those men, I see men who have very low levels and have no symptoms, and I might follow those men once a year or they know to come back to me if they become symptomatic. But I try to educate them as to what they can do lifestyle-wise to improve or raise their levels.
E. David Crawford: You were one of the first that years ago told me about the GLP-1 drugs and the Ozempics and things that were around that we're going to hear about this, about weight loss, and you were absolutely right. It's an epidemic of that going around. Does correcting the weight and weight loss improve testosterone in men, muscle mass?
Martin Miner: It certainly can improve. Correcting the weight, improving sleep, because many of these men have sleep disorders. And by the way, these clinics aren't really looking at any sleep issues on these men. They're not looking at mood issues, they're not looking at sleep. These are often manifestations of testosterone deficiency. It's a multifactorial issue and it's truly an art. And there are guidelines about the use of testosterone therapy just as there are guidelines about the use of the GLP-1 meds for weight loss.
E. David Crawford: You just said something about COVID, which I sort of knew, but is that—did patients recover from that? The low T that occur?
Martin Miner: They often do, but sometimes it takes between 12 and 15 months. And if they're really symptomatic, I will treat those men for a time to help them recover. And then we might do other things like use Clomiphene or human chorionic gonadotropin low dose to re-stimulate their testosterone recovery. But the issue of these clinics, what came out particularly negative is that these are more of financial mercenary clinics, which call themselves men's health centers but really aren't interested in health at all. They're interested in getting a group of individuals who are paying a monthly subscription fee between, I think, $1,200 and $2,600 a year, paying $100 to $200 a month for a medication that can be purchased at CVS or Walgreens for between $12 and $30.
E. David Crawford: With a prescription, though. Let's move on to the risk in the last couple minutes here. I know that the testosterone replacement therapy was sort of on the watch list with the FDA and concerns about restricting it. There was a study that you're very familiar with, involved with, called the TRAVERSE study.
Martin Miner: That's correct.
E. David Crawford: What was the take-home message from that study that changed all of this with testosterone and cardiovascular—
Martin Miner: The TRAVERSE study showed that there was no increase in cardiovascular endpoints, in cardiovascular events including heart attack and stroke, from the use of testosterone therapy in the form of a testosterone gel in up to 5,500 men for a median of about 33 months. Back in 2015, the growth of testosterone therapy, as pointed out by this article accurately, was quite significant. It was one of the fastest-growing drugs when the topical AndroGel was introduced by AbbVie. And because of that, the FDA was very concerned with a couple of cross-sectional studies, poorly done studies, but they did show an increase in heart attack and potential strokes. That is not the case. Testosterone does not appear to be associated with an increase in heart attacks and strokes. That's testosterone replacement.
However, the most commonly used testosterone are the injectables, and we haven't really studied those for safety with the same scrutiny as this long-term safety study. So I still am concerned about the polycythemia or the increase in hematocrits that we see with the use of testosterone therapy. There's no concern or little concern anymore about the relationship of testosterone causing prostate or breast cancer, which there originally was a significant amount, as you know prior.
E. David Crawford: That was always a significant fear. That sort of got me interested in TRT. Two more things here. One is diabetes. There's a study ongoing with that too, right, with testosterone replacement?
Martin Miner: The T4DM study, the large Australian study, which showed that testosterone therapy actually induced a remission together with lifestyle and exercise. So those two can't be ignored. Lifestyle and exercise together with testosterone therapy induced a remission of type 2 diabetes, and I think it was largely facilitated by the weight loss that accompanied the interventions. So the men that I see, David—and this gets back to your first question, who should be treated—the men that I see often have no motivation to exercise, and the only way to get them to exercise or to sleep better is to use testosterone. I look at it as a tool, which we can use anywhere from 12 to 24 months. Some men may be on it indeed indefinitely for a longer period of time, and I think it's generally safe, but it should not be given to men of this age group, which is the 30- to 40-year-old age group. And I don't give it to those men in my practice unless they clearly understand that it could impair fertility, which is one of the points of this article.
E. David Crawford: And then the withdrawal and things like that. Marty, it's great having you on.
Martin Miner: Yeah. It's always wonderful.
E. David Crawford: I think this article really was well written and it did bring forward the concerns about this, the widespread use of testosterone replacement. There's a lot of variables and we need experts like you and educated urologists and others and family practice doctors to properly diagnose and treat these men so we don't have this sort of problem. Thank you so much, Marty.
Martin Miner: Thank you, David.
E. David Crawford: We appreciate it.
Martin Miner: Yeah, anytime.