A Food and Drug Administration panel of health experts convened Wednesday to discuss and promote the health benefits of testosterone treatments for men.
FDA Commissioner Martin Makary told Morning Edition that low testosterone is believed to be associated with symptoms in roughly one-third of men who have it, though he said the evidence and data are not fully defined. Symptoms can include “reduction in mood and vitality,” Makary said.
Speaking to NPR’s Steve Inskeep, Makary discussed why the FDA wants to reconsider medical access to testosterone and the stigma associated with its use.
Listen to the full conversation by clicking the blue play button above.
The radio version of this story was edited by Adam Bearne and produced by Lilly Quiroz. The web copy was written by Obed Manuel and edited by Majd Al-Waheidi.
Audio transcript
STEVE INSKEEP, HOST:
The Food and Drug Administration is leaning into testosterone treatments. The FDA conducted an expert panel this week that promoted their potential benefits. Studies show testosterone levels have declined broadly in men. So what to do about that? Marty Makary, the FDA commissioner, came by our studios to suggest that taking a testosterone shot or patch may help.
What does it matter if testosterone levels go down? How are people affected by that?
MARTY MAKARY: Generally speaking, it’s believed to be associated with symptoms in roughly a third of individuals with low testosterone. Now, the studies aren’t very well-defined, so it may be more, and we just don’t appreciate it. But the symptoms are reduced strength, a reduction in mood, sometimes depression, a reduction in vitality and a reduction in libido.
INSKEEP: Now, I did my own research, as a layman might. I looked up some things from the Cleveland Clinic. They strike me as fairly credible. And when I read their description of testosterone, what the problem is and what to do about it, I get the impression that it may have a lot to do with a sedentary lifestyle, obesity and that you can reverse the problem with the right kind of exercise. Is that correct?
MAKARY: It’s not clear which comes first, the chicken or the egg. Is it the sedentary lifestyle that reduces your testosterone, or is it an underlying baseline lower testosterone level that contributes to those symptoms? The general feeling among the FDA experts that we convened recently was that it’s the low testosterone that then contributes to the reduction in mood and vitality.
INSKEEP: When I was reading this analysis, it was suggested that the right kind of exercise will quickly bring up testosterone levels. Is that correct?
MAKARY: It does appear to be modifiable to some degree. But we are talking about roughly 30% of the population over age 30 having low testosterone. And a large portion of them have symptoms.
INSKEEP: Which is why Makary says he wants doctors and patients to get over an aversion to treatment.
MAKARY: And that may be in part because it got deemed a possible carcinogen, as causing prostate cancer, and the doping scandals of the Olympic athletes in the ’80s and ’90s.
INSKEEP: People were using testosterone to compete unfairly.
MAKARY: That’s right.
INSKEEP: So it became more restrictive in that time. You want to make it less so, easier to get.
MAKARY: That’s the proposal, because right now, testosterone is a controlled substance, according to the DEA. If your doctor recommends testosterone, you almost feel like an addict when you go to pick it up from the pharmacy. The doctors who presented at the FDA said we’ve got to remove that stigma and use an evidence-based approach.
INSKEEP: Are you concerned about the side effects of potentially millions more people taking testosterone?
MAKARY: You know, the field of hormone replacement therapy for postmenopausal women is far more mature. With testosterone therapy, it’s less established. Now, we have incredible data points from experiences, physicians who have treated thousands of patients. We also have a couple large studies which confirmed that there are not the cardiovascular or prostate cancer downsides that many physicians were concerned about. So it’s really one of those things now where we need to do more research, but also present people with the options.
INSKEEP: Secretary Kennedy often speaks, I heard him speak recently, about a health care industry that profits off of medicating people. Are you concerned about being pushed around a little bit by companies that want to sell this?
MAKARY: Look, we have to be vigilant about corporate influence at the FDA. The agency that I run has in its history been captured by the industry that it is supposed to regulate. But at the same time, testosterone and estrogen, in the case of postmenopausal women, are hormones that naturally appear in the human body. So we’re talking about replacing those hormones or supplementing the level so that people can experience the benefits they had before those levels declined.
INSKEEP: A couple of years ago, Secretary Kennedy himself said that he used testosterone, I believe as part of an antiaging regimen.
MAKARY: Yeah, you know, I learned about that after our FDA expert panel recently. I read that somewhere, so that’s interesting.
INSKEEP: You hadn’t discussed that with him previously?
MAKARY: No, no, we hadn’t discussed that.
INSKEEP: Has he been an advocate of testosterone?
MAKARY: We hadn’t discussed it. But there are 10 million men who are using testosterone. And many describe an ability to workout more efficiently, to build muscle strength. And the muscle strength piece is interesting because it turns out that the No. 1 predictor of longevity is muscle mass. Now, the association between testosterone and longevity has not been established at this point.
INSKEEP: Right.
MAKARY: But men live on average seven years shorter than women. And one theory has been that it may be related to the decline in testosterone reducing muscle mass.
INSKEEP: Marty Makary is the FDA commissioner. We also asked him about vaccines.
MAKARY: Vaccines save lives.
INSKEEP: And trust in the Department of Health and Human Services. We’ll have his answers on Monday.
