The problem, the experts said, is that nobody has been listening to men.
For too long, hormone therapy has been inaccessible for cisgender men who need it — or so said clinicians, professors and a pharmaceutical CEO gathered this week by the Food and Drug Administration (FDA). Testosterone, a controlled substance, should be deregulated and patients should be able to access it at pharmacies without stigma, they said. Low testosterone in men is not just a cosmetic issue, they claimed — it’s an American health crisis.
Experts at Wednesday’s FDA panel presented a unified and mostly rosy view of testosterone, praising it as the answer to common ailments that follow men as they age: weight gain, loss of muscle mass and exhaustion. Their need for more testosterone is dire, the panel claimed, to prevent disease and premature death. Millions of men are at risk of low testosterone and aren’t being screened for it, they said.
Not all medical experts agree on these broad claims, and some criticized the FDA panel for lacking key context about the risks of taking testosterone. Regardless, FDA Commissioner Dr. Marty Makary made it clear that the agency is interested in revisiting testosterone’s current label as a drug with a higher risk of abuse and physical dependence. With that label comes restrictions on refills and penalties for possessing it without a prescription.
In the past, transgender rights advocates and Democratic members of Congress have asked federal agencies to loosen these restrictions, which would make it easier for trans people to access the hormone as part of gender-affirming care.
But Wednesday’s panel was clear in its singular focus: how testosterone could improve cisgender men’s health.
“Testosterone therapy is safe, effective, and preventive,” said Dr. Helen Bernie, an associate professor of urology at Indiana University, where she directs the school’s male sexual and reproductive medicine program. “Testosterone is still regulated as if it were a dangerous performance-enhancing drug. … Because of this outdated classification, many physicians fear prescribing it or even screening for it.”
Another panel expert — Abe Morgentaler, a Blavatnik faculty fellow in health and longevity at Harvard University — lamented that “the demonization of testosterone is a tragedy.”
“In what other area of medicine does one get to hear your patients tell you that they have improved mood, vigor, sexuality — and then to hear on a regular basis, ‘Finally, I feel like myself again?’” he said at the FDA’s panel.
To some transgender men, such statements coming from an event organized by the Trump administration are laughable. The White House has denounced hormone replacement therapy — when used by trans people — as part of an effort to “eradicate the biological reality of sex.”
But cisgender people rely on hormone therapy, too. And some men clearly want more of it.
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“It seems like these officials know quite well how important it is for people to have easy access to medications that improve their health and improve their lives,” said Zan Lussier, a 56-year-old transgender man living in Washington state. “It absolutely is gender-affirming care for cis men.”
Lussier has been on testosterone since March 1999. Back then, he couldn’t just go directly to his general practitioner and say what he needed. It took time to find a medical professional willing to prescribe him testosterone and even then, it was kept out of his medical records.
“Welcome to what some of us have been dealing with since the late ’90s,” he said. “But it’s much easier for them. There were not ‘Hims’ commercials in 1999.”
Many transmasculine and nonbinary people take testosterone to alleviate the distress of gender dysphoria, which can cause serious mental health problems. Lately, their access has been threatened because of politics. Late this summer, Lussier watched as a local clinic stopped providing gender-affirming care to trans youth as a result of funding threats from the federal government. Clinics across the country have followed suit.
At Wednesday’s panel, Shalin Shah, CEO of Marius Pharmaceuticals, said that the Department of Health and Human Services should consider testosterone therapy an essential health benefit to reduce barriers to access. The Trump administration recently finalized a rule barring insurers from covering gender-affirming care as an essential health benefit — meaning trans people’s costs for the same treatments would be higher.
Dr. Alex Dworak, a family medicine doctor based in Omaha, Nebraska, regularly prescribes testosterone to both his cis and trans patients. The benefits are often the same for cis and trans men, including improved overall well-being, better mental health and physique, and increased libido. For trans men, benefits also include developing a deeper voice, growing facial hair and ending the menstrual cycle, which alleviate the stress of gender dysphoria.
Removing the Schedule 3 label for testosterone makes sense, Dworak said. A false sense of fear still lingers around its use as a medication, he said, just as some patients and providers were scared away in the early 2000s from using estrogen to treat menopausal symptoms. But although he agrees with much of the FDA panel’s discussion, he was struck by who was left out of the conversation.
“If it is legit here, why is it any less legitimate for gender-expansive people? If it’s good for cis men, why is it bad for trans men?” he said.
When discussing testosterone for trans people, the tone is completely different, Dworak said; the federal government is questioning the legitimacy of gender-affirming care, taking down research, and stigmatizing the community. But it’s the exact same medicine, he said.
“I’m struck by the hypocrisy and the contradictions,” he said. “You can’t recognize this value for one group of people while simultaneously questioning or frankly demonizing that value for another group of people.”
However, not all experts agree about the benefits. Dr. Adriane Fugh-Berman, a professor of pharmacology and physiology at Georgetown University Medical Center, criticized the FDA panel for glossing over known risks of testosterone treatment for men — including high blood pressure and a higher likelihood of blood clots.
“Panelists claimed that testosterone would prevent cardiovascular disease, diabetes and osteoporosis, despite a stunning lack of evidence in support of these claims,” she said in a statement as director of PharmedOut, a research project on the effects of pharmaceutical marketing. Panelists noted that low testosterone is associated with obesity, diabetes and cardiovascular disease, she said — but they failed to mention that these conditions may decrease testosterone levels, not the other way around.
Ashton Colby, a 33-year-old trans man living near Columbus, Ohio, can feel it when he misses his weekly dose of testosterone. In the past, he’s had to go without it for months at a time due to a lack of insurance. He lost muscle mass, body acne came back, his period came back, and his mental health was severely impacted. He felt depressed. That’s why restrictions on trans people’s access to hormones and gender-affirming care freak him out.
Colby’s primary care provider, a nurse practitioner, measures the testosterone levels in his blood a few times a year. The desired range is the same for him as it is for cisgender men. If his levels drop below that, they raise his dose. To him, there is no difference between the medical care that he gets and what cisgender men get — except that his care has been under attack.
“There’s a real empathy moment that could be had here for these folks,” said Lussier, the trans man living in Washington state. Many trans people utilizing gender-affirming care have to deal with the same issues that experts on the FDA panel raised for cisgender men: like medical gatekeepers and uncomfortable interactions with pharmacists. But they go through with it anyway.
“Because, as they said, this is the only way I can feel like myself. Without testosterone, I am not who I am,” he said.
Great Job Orion Rummler & the Team @ The 19th Source link for sharing this story.
