[0:00]Why is testosterone replacement so difficult to get? Why do so many doctors say no and what can we do about it? Well, the FDA gathered on December 10th of 2025 to talk about testosterone replacement therapy, and I watched it so you don't have to.
[0:13]I'm Dr. Rena Malik, urologist and pelvic surgeon and welcome back to the Rena Malik MD podcast, your source for leveling up your health, sex life and relationships with evidence-based tools.
[0:22]Today, I'm talking about the FDA panel on testosterone replacement therapy. I am so thrilled that we are finally talking about hormones at a governmental level, because so many regulations come from the FDA.
[0:35]What sort of labeling is on medications that we prescribe to you, how easy or difficult it is to prescribe those medications? And some of those are for good reasons and sometimes it's not for good reasons.
[0:44]Now, I think this panel was really well done for the most part, it includes a wide variety of experts, some urologists who are my colleagues who've been on this podcast before, who are very well versed in literature, who've done the research themselves, who've treated thousands upon thousands of men with low testosterone.
[1:00]However, there were some things I would critique and I'll go through it with you. Dr. Marty Macari, who is the US Commissioner of the Food and Drug Administration, starts off the expert panel by really underselling testosterone.
[1:12]And it actually highlights exactly the reason that they needed to have this panel in the first place.
[1:17]There are far fewer research studies demonstrating the detailed benefits or potential benefits of testosterone therapy.
[1:27]The data are emerging. We are here today to listen to the experts and to learn. Another important difference is that there are more unknowns when it comes to the potential clinical benefits of testosterone in men.
[1:41]So, as I mentioned earlier, I do think they chose very good experts. However, I will tell you that they did disclose some of them were consultants for companies that make testosterone, and one of the physicians was also a consultant for Hims, which is a company that offers online platform for metabolic health.
[1:58]Also, one of the participants was a CEO of a pharmaceutical company that creates oral testosterone.
[2:04]Now, obviously, that is a clear bias. This individual is very vested in how many people get prescribed testosterone.
[2:11]So that did give me a little bit of pause, but I think ultimately the other things that were talked about and the other experts were very, very well versed and very unbiased.
[2:20]And even listening to the CEO, who I've met in person, who's actually a very nice person, was for the most part, very helpful and useful information.
[2:27]So, they started off by sort of discussing what the problem is, and low testosterone is a real problem.
[2:33]So, let me back it up a little bit. Testosterone receptors are all over our body.
[2:37]And when you have low testosterone, it can affect your quality of life, your brain health, your mood, your muscle health, can cause muscle obesity.
[2:44]And when you have normal testosterone, it actually reduces the risk of chronic conditions, like diabetes, osteoporosis.
[2:50]And when you look at the data, it estimates that about 20% of men are suffering from low testosterone.
[2:56]And Dr. Motkera started off by describing this very eloquently.
[3:00]It is not a cardiovascular risk factor. It's not merely a lifestyle drug.
[3:07]What we do know is that testosterone plays a very important role across multiple organ systems throughout the body.
[3:11]In fact, testosterone deficiency negatively impacts health, reduces quality of life, and increases the risk for mortality.
[3:20]Testosterone therapy offers multiple clinical benefits, such as improvements in diabetes, obesity, and bone mineral density.
[3:28]So, what is testosterone and how common is testosterone deficiency?
[3:32]Well, testosterone is a natural hormone in both men and women. It is not a foreign substance.
[3:39]Testosterone is produced primarily by the testicles in men from a signal that's regulated from the brain.
[3:44]But in puberty, testosterone drives male sexual development, and in adult men, it supports energy, muscle mass, libido, erectile function, bone mineral density, and even mood.
[3:57]Many people don't realize that testosterone levels decline only modestly with age, but far more rapidly when someone gains weight, they develop diabetes, or they develop a chronic health condition.
[4:08]In other words, the term age-related hypogonadism is misleading.
[4:13]Aging alone has minimal impact on testosterone levels, comorbidities, not age itself, are the main drivers of significant decline in serum testosterone levels.
[4:24]Testosterone deficiency is a very prevalent condition.
[4:27]As you heard earlier, 5.6% of men between the ages of 30 and 79 suffer from testosterone deficiency.
[4:34]In fact, some studies have shown that up to 18% of men over the age of 70 will suffer from testosterone deficiency.
[4:41]But here's the problem. Only 5 to 20% of men who suffer from testosterone deficiency receive therapy.
[4:48]There's a big gap. This gap is a reflection of misconceptions about providers, it's barriers to access, and it's a lack of awareness for providers and patients.
[4:57]I think it's important to realize that testosterone goes beyond just muscles and sex.
[5:02]Low testosterone is strongly associated with poor overall health in men.
[5:07]For example, did you know that men with low testosterone levels are 17% more likely to have cardiovascular disease?
[5:14]Men with low testosterone levels are 50% more likely to break a bone, men with low testosterone levels are 52% more likely to have diabetes, 69% more likely to have obesity, and 86% more likely to suffer from depression.
[5:29]Some studies have shown that men with low testosterone are six times more likely to have male infertility.
[5:35]And what I find most concerning is that you look, men with low testosterone levels are twice as likely to have all risk for all cause mortality compared to men with normal testosterone levels.
[5:45]Guys, I want to point out some of the numbers he mentioned. 50% more likely to break a bone if you have low testosterone.
[5:52]Now, that has serious implications. Later in the panel, they have Dr. Richard Aori, an orthopedic surgeon, who explains the relationship between bone health and low testosterone.
[6:02]20% of elderly men with osteoporosis have low T.
[6:06]66% of elderly men with hip fractures have low T. Think about that.
[6:14]And 20% of the males with spine fractures have low testosterone.
[6:18]Hip fractures in elderly males result in a 31% mortality in one year after fracture, and that's much higher than in the female population.
[6:27]And what really shocked me was that the mortality risk after hip fracture in elderly men was 31%.
[6:36]I have always quoted 20% because generally that's the risk in adults, but I didn't know that the risk was actually 10% higher in men.
[6:44]This means that, guys, low testosterone really puts you at high risk.
[6:48]Now, Dr. Mulhall described the signs and symptoms of low testosterone.
[6:52]And he showed this slide, which really sums it all up, and you can take a screenshot.
[6:57]Dr. Mulhall describes this really, really well. He calls it a decrease in overall life productivity, and I think that encapsulates it perfectly.
[7:05]My patients who have low testosterone, they don't feel like themselves. They are not working at their peak level.
[7:11]They are not having good relationships with their partners because of the side effects, the sexual side effects of low testosterone. They're not moving the same way.
[7:18]They may have gained weight, and overall, this is contributing to loss of productivity.
[7:23]And, you know, people can care about all sorts of things, but everyone cares about productivity, right?
[7:28]We want people to work, we want people to contribute to society.
[7:31]And so, this is a huge global issue, and specifically, we need to address it as such.
[7:37]They also went on to discuss sort of the research, and they started talking about the traverse trial, which was done in 2023.
[7:42]And I've talked about it previously on my YouTube channel, but let me summarize for you guys.
[7:46]It's the largest randomized placebo controlled trial ever published on testosterone.
[7:50]Over 5,200 men received either testosterone gel or a placebo.
[7:56]And these guys were over 45 years of age and they had existing heart disease or carried other risk factors like high blood pressure, diabetes or being overweight.
[8:05]And so when they randomized these guys, they followed them for up to nearly three years, and they basically found that testosterone didn't increase the risk of heart attack, prostate cancer, and it didn't worsen urinary symptoms.
[8:17]These are all misconceptions that many physicians have carried for many, many years.
[8:22]And this was because a few controversial studies got a lot of press attention.
[8:27]I will say that when you have a negative thing, right, something that's negative, it's actually significantly more likely to grab people's attention.
[8:35]If I tell you, this is good for you, you're less likely to pay attention, but if I say, hey, this is bad for you, you have to stop doing this, people listen.
[8:44]And so it makes sense that when you're saying, hey, this study showed testosterone caused prostate cancer, even if the study was flawed, even if the statistics weren't done correctly and they didn't really look at it too carefully, a lot of people are going to pay attention.
[8:57]Now that we know that testosterone doesn't cause heart disease or prostate cancer, very few people know that.
[9:03]In fact, many physician colleagues still mistakenly believe that it does.
[9:07]And so they tell their patients this information, who then say, no, I don't want to take testosterone, it's too dangerous.
[9:12]When it could actually really improve their quality of life, their health, their overall productivity, and they're, you know, spreading this information far and wide.
[9:19]So, thank you guys for listening because that is exactly why I create content, I make this podcast, I make my YouTube channel, because I want to share evidence-based information that is accurate.
[9:29]Dr. Marty Miner shared some additional data about testosterone and how it's impacting the metabolic and cardiovascular health.
[9:38]The T4 DM is a a seminal study.
[9:44]It involves the testosterone treatment to prevent or reverse type two diabetes, published in 2021 in Lancet Endocrinology.
[9:53]This was a randomized, double blind, placebo controlled, two-year trial of 1,007 men between the ages of 50 and 74.
[10:02]All with visceral adiposity, all at risk for new type two diabetes or newly diagnosed with type two diabetes.
[10:10]They were assigned to either a testosterone and decanoite injection or placebo plus lifestyle.
[10:17]The findings showed that testosterone plus lifestyle reduced type two diabetes prevalence by 41% and enabled 13 more percent men to reverse their diabetes compared to lifestyle plus placebo.
[10:34]The Basaria study looked at three years of testosterone therapy on subclinical atherosclerosis, published in 2015 in JAMA.
[10:46]This study showed that three years of testosterone gel in older men with low or low normal levels did not significantly change carotid intimal medial thickness.
[10:59]There was no progression of subclinical atherosclerosis with testosterone therapy.
[11:03]Now, the next issue is one that I think is super important that the panel brought up and this is that it is a regulatory problem.
[11:10]Testosterone is a regulated substance. It's a schedule three controlled substance.
[11:15]Which makes it very difficult to prescribe. It's difficult to prescribe and the prescribers get worried about having patients take this medication because it might cause abuse.
[11:25]And this sometimes prevents doctors from prescribing the medication.
[11:30]Also, it may become more difficult to prescribe over telemedicine.
[11:34]So, during COVID-19, they put out a waiver allowing people to prescribe controlled substances over telemedicine.
[11:40]Now, that waiver may go away, making it more difficult to do that without a face-to-face visit, meaning that you actually have to find a doctor close to you that is willing to prescribe testosterone if you are having low testosterone.
[11:51]And the issue is that most people are, again, facing these challenges and not prescribing it.
[11:56]And Dr. Mohera talks about this in the panel.
[11:59]Testosterone and its derivatives are the only natural hormones classified as a schedule three controlled substance.
[12:07]A designation that has no evidence base and only contributes to ongoing stigma and heightened safety concerns.
[12:14]Dr. Helen Bernie, another urologic colleague, she explains this really well.
[12:18]Testosterone is still regulated as if it were a dangerous performance-enhancing drug from the athletic doping scandals of the 1980s.
[12:25]And because of this outdated classification, many physicians fear prescribing it or even screening for it.
[12:32]Dr. Landon Trost, another urologist, he explained the history of this regulation, relating back to the anabolic steroid control Act of 1990, which was done actually in response to the abuse in both bodybuilding and athletics.
[12:45]Now, he also mentioned there's actually no concern that anyone can get dependent on testosterone.
[12:51]And importantly, there's no evidence to suggest dependency at any physiological levels with testosterone.
[12:57]In contrast, things like narcotics, these other things do have dependencies that occur at physiological levels.
[13:01]And Shahlin Shah, the CEO for Meris Pharmaceuticals echoed his sentiments.
[13:06]Testosterone has lower abuse potential than caffeine, yet it is regulated more tightly than cannabis in half of this country.
[13:13]Now, they are correct that when you're taking testosterone at therapeutic levels, meaning you're getting testosterone, it's at physiologic doses, there has been no evidence of addiction or dependence.
[13:24]However, if people are using high doses of anabolic steroids or testosterone, 30 to 35% of them develop a dependence syndrome.
[13:34]That's one in three. And the thought is that it activates the reward pathways in the brain, called the mesolimbic dopamine system.
[13:40]And in humans, they suspect that this starts with body image dysmorphia or concerns that they don't have enough muscle, and then people become obsessed with getting a specific body type.
[13:51]And then it can progress into classical sort of drug dependence patterns, meaning they're taking higher doses, they're using multiple steroids at once, and they continue taking it even though it has serious health problems.
[14:04]And the other issue is there's a withdrawal syndrome.
[14:07]If you stop using these high dose steroids, they experience profound depression, fatigue, loss of libido, intense cravings, and sometimes even suicidal thoughts.
[14:19]I'm bringing this up because this is the reason there's so much concern around testosterone use because when people abuse these medications, whether it's testosterone or other anabolic steroids, it has significant consequences for your health.
[14:32]But on the flip side of that, if you are not accessing testosterone, you will end up finding it elsewhere.
[14:38]I've had patients tell me they're getting testosterone from God knows where because their doctor wouldn't prescribe it or they're buying it from a different country.
[14:45]And then we don't actually know if that is pure testosterone or there's other sort of things mixed into it.
[14:52]Is there adulteration of the compounds? We don't know. Now, in response to that, there has been a rise in online prescriptions of testosterone.
[14:59]And there's actually been evidence to suggest that when people get testosterone from these online clinics, there was actually a paper on this by my colleague Justin Dubin, where they are able to get testosterone one when they have completely normal testosterone levels.
[15:10]And two, they are not counselled on the risks. Now testosterone is not without risk. I have painted a very rosy picture of testosterone because it is very rosy in many circumstances, but there are no free lunches.
[15:19]If you take testosterone, there are risks and you need to be counselled about those risks.
[15:24]And so that is the challenge is that people don't really get this information, particularly they are not told about the risk of infertility.
[15:31]And Dr. Larry Lipschutz explains this very well.
[15:34]So, why is this going on? Well, we know that testosterone prescriptions have tripled in the United States over the past 10 years.
[15:43]Men, I think these are two important reasons. Men are presenting and being treated for very non-specific symptoms, for example, fatigue, and we've heard today, there are very specific symptoms that go along with hypogonadism.
[15:57]And I think even more importantly, we're seeing a fantastic increase in online prescribing by MDs and non-MDs alike.
[16:08]And the young man that I'm concerned about are going to be going to the internet and easily getting these prescriptions.
[16:13]Now, guys, young men are the ones that we worry about for these long-term issues.
[16:17]One is that testosterone is for lifetime. Generally speaking, when I start patients on testosterone, I tell them, you are going to need this medication likely for the rest of your life.
[16:26]Yes, you can come off of it, but at in the interim, when you come off of it, your body has now stopped making its own testosterone because it's been told that it has enough, right?
[16:35]It's getting these signals from the body that it has an abundant amount of testosterone, so it's not sending signals to the testicles to make testosterone.
[16:42]And number two, it causes infertility that's sometimes irreversible.
[16:47]It's really, really important for people getting these medications to get understand these consequences.
[16:51]Yeah, I think one of the uh misconceptions is that it takes a lot of testosterone to impair fertility and it doesn't.
[16:58]Very low doses of testosterone will turn off sperm production in a fairly short period of time.
[17:06]So, we don't want to make we don't want people to think they're safe if they take just a little bit.
[17:11]The panel even talked about supplements and testosterone boosters.
[17:15]I was really surprised, but I was actually happy to see this.
[17:18]A urologist, Dr. Ted Crisostomo, Win, he's a urologist and as well as a active duty soldier and a physician, and he talked about the risks with supplements.
[17:27]In a recent study, the supplements that are marketed for sexual enhancement and muscle building, which includes these testosterone boosting supplements, have the highest rates of adulteration, meaning they include other other medications or even banned substances.
[17:39]Some of them have been found to include testosterone itself or even anabolic steroids within the the supplement.
[17:45]He also talked about the issues with getting testosterone when you're in the military, which I found really, really fascinating.
[17:50]I'm not going to belabor that here. If you want to learn more about it, I'm happy to make a video about it on my YouTube channel, so comment either on Spotify or on YouTube.
[17:57]So I'll see that, and if you want to learn more, I'm happy to talk about that.
[18:00]They again talked about super physiologic abuse, because again, it's something that we can't ignore.
[18:06]So studies estimate that about 3.3% of people around the world have used anabolic steroids or substances that raise testosterone to super physiologic levels.
[18:16]In the US alone, they suspect that 1.3 to 4 million Americans have used anabolic steroids, which with about 100,000 new users each year.
[18:27]And what's really more concerning is that people are getting these drugs from really crazy sources like online or through gym dealers, not prescriptions from their doctors.
[18:36]And again, then they're not understanding what is actually in the substances they're taking and what it does to their bodies.
[18:42]Now, people take this because steroids enhance muscle growth and strength fairly quickly.
[18:47]But the consequences are real. Heart attacks are 15 times more common in steroid users, and premature death is over 120 times more likely.
[18:55]They can have side effects like enlarging your heart, causing arrhythmias, increasing blood pressure.
[19:01]They can damage your liver, for taking oral medications, lead to infertility, which we've talked about, testicular shrinkage, and cause serious mental health problems like aggression, anxiety, and depression.
[19:14]In some cases, even kidney damage. And when you're taking these, because your muscles get so big and they're growing so fast, your tendons and your bones are not adept at handling that muscle size.
[19:24]So you're more prone to muscle and tendon injuries.
[19:27]Now, Dr. Toby Kohler goes into a little bit of this information.
[19:30]He said that testosterone levels above 1800 are clearly the sort of cutoff of being super physiologic, based on a study looking at natural testosterone levels in about 1500 men.
[19:40]He also shared some interesting data evaluating men who were abusing testosterone.
[19:46]And on average, when you looked at these men, most of them had a testosterone level of even higher than 2,370 nanograms per deciliter, which is more than two times the normal amount.
[19:55]I'd like to highlight one specific study, which took 43 men and randomized them to getting a big dose of testosterone, 600 milligrams a week, about six times normal.
[20:07]And they had half the men exercise and half the men not, and then half the men got the drug and half got a placebo.
[20:12]The results are quite uh illustrative.
[20:15]So, this is for bench press and squat performance.
[20:18]Men who received testosterone but sat on the couch, yes, they got stronger.
[20:24]But look at the men who actually went to the gym and moved iron. They actually did better without any anabolic steroids.
[20:32]They got stronger and better because they exercise. I was actually surprised by this. I had not seen this data, and so basically, if you added testosterone to exercise, the results were better, but exercise was needed.
[20:44]If you just took testosterone alone, it didn't even rival the results with exercise alone.
[20:48]Now, the next big sort of part that was discussed in the FDA panel was the difficulty of treating testosterone deficiency.
[20:54]And why the cutoffs were what they are. So the guidelines in the American Urological Association recommend a cutoff of less than 300 nanograms per deciliter.
[21:03]But Dr. Mulhall explained exactly how that was determined. And that is when we reviewed in the systematic review with meta-analysis, methodologist reviewing the entire body of the world's literature and we looked at placebo control trials.
[21:13]Uh, the entry criteria for getting into those studies, the median uh T level was 280 or thereabouts.
[21:22]So, that's why we use 300 as a cut-off. However, if you look at the supporting texts, it's clearly documented that we recognize that there are men who have T levels above that, who are highly symptomatic, who are worthy of consideration for testosterone therapy.
[21:36]He also mentioned that testosterone affects different organs at different threshold values, which means that depending on what sort of benefit you're looking for, you might actually need a different level.
[21:47]So, bone mineral density probably is in the 280 range, infertility is going to be in the 50 to 100 range, erythrocytosis maybe 6, 700, 800 range.
[21:56]And so it's challenging because depending on what specifically you're looking for in the study, the population you enroll is going to help determine the extent of effect you're going to see from it.
[22:04]But no question when you get above 350, you're going to get placebo type responses with anything where you're not going to see an effect and the lower you go, the more likely you'll see a treatment benefit.
[22:13]So, I would just uh encourage that the idea that there's a bright clear line where you can draw a line, a threshold where men below that number are symptomatic and will benefit and men above it should not be treated, that line doesn't exist.
[22:29]Now, another thing came up, which was, should we be screening for testosterone deficiency?
[22:35]Dr. Bernie, Dr. Mulhall and others encouraged having screening.
[22:39]Now, here's my take on that. I think having a baseline level when you're feeling good in your 20s to 40s, anywhere in there is a good idea.
[22:47]Because we want to know what your testosterone was when you felt great. However, when you get symptomatic, then you can test again and see if there's a major difference.
[22:56]But I do think that we need to be cautious. Testosterone is extremely variable.
[23:01]It varies throughout the day by the season even.
[23:04]So it's important that we're not chasing some magical number like, oh, I want to be 800.
[23:09]You want to actually be looking at, are you having symptoms, and if you try testosterone, is it actually improving those symptoms?
[23:15]Also, this is a really interesting point. But interesting, when you look at young men, so this is men in their 20s and so on, who have low testosterone up to 30, 40% of them have osteopenia.
[23:23]And so if you're finding a high rate of disease in men who have low testosterone and there's not a high risk in identifying false positives or anything like that, that pushes much more heavily towards a general screening type test.
[23:35]And Dr. Bernie mentioned how screening would be helpful because we might be able to catch people before they lose muscle mass or bone health and do something about it.
[23:44]Earlier intervention is going to allow you to implement changes before they fall, before they lose their independence, before they get a fracture.
[23:53]Now, here was one thing that I didn't agree with fully, and this was a comment made by Shahlin Shah, who was a CEO of Merius Pharmaceuticals about needing to take testosterone with GLP-1s.
[24:02]We need to fast track an approval to use testosterone alongside GLP-1s in order to prevent a frailty crisis.
[24:09]Now, to my knowledge, there's currently no evidence that you need testosterone to maintain muscle mass on GLP-1s.
[24:16]And this is because when you lose weight, no matter how you lose it, whether it's weight loss or with the GLP-1, you are going to lose muscle mass.
[24:23]The issue with GLP-1s is you lose an appetite.
[24:26]And so if you don't eat enough protein, you will lose more muscle mass.
[24:29]But if you exercise and you eat sufficient amounts of protein, you should be able to maintain your muscle mass.
[24:36]I don't think that it's required that every person who gets a GLP-1 should be put on testosterone.
[24:43]I think that it is a consideration if you have symptoms of low testosterone and they are bothersome and there's and you're having issues.
[24:51]But I don't think that if you haven't tried to maintain your diet and exercise to maintain muscle mass, that's inappropriate.
[24:59]You are going to lose muscle mass when you lose weight, if you do nothing. If you maintain the same diet and you lose weight and you haven't increased your protein intake, you will lose muscle mass, and you can see that even in people who lose weight naturally.
[25:08]Now, there were some really nice comments that I'll leave you with from the panel, and I think they really say it perfectly.
[25:14]Testosterone replacement therapy needs to be accessible, safe, and managed appropriately.
[25:20]And there are obviously current limitations within the system that make it difficult for us to do our job and for you to get access to good care.
[25:26]The demonization of testosterone is a tragedy.
[25:32]The smug dismissal of men suffering from testosterone deficiency is a scandal.
[25:38]And the failure to teach testosterone deficiency to medical students is a stain on my generation of medical educators.
[25:46]This is not enhancement. This is restoration of health and dignity.
[25:50]Did you guys learn a lot about testosterone in this episode? I certainly hope you did and I hope I saved you an hour and 45 minutes of watching the FDA panel.
[25:57]If you guys have enjoyed this episode and you've been watching me or following me, please make sure you're subscribed or following the podcast on whatever platform you're listening.
[26:05]This is super important because it signals to podcast platforms that people want to listen, and so they show it to more people and it allows more people to get this kind of information.
[26:12]I hope you enjoyed it and as always, remember to take care of yourself because you are worth it.
