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Telehealth sites promise cure for 'male menopause' despite FDA ban on off-label ads

Michael Scaturro, KFF Health News on

Published in News & Features

Several websites reviewed by KFF Health News brand themselves as news and fitness magazines, with advertisements embedded in articles steering readers toward order forms for testosterone replacement therapy, shorthanded as TRT. The sites’ prices for TRT range from $120 to $135 a month, not including initial mail-back blood tests for around $60. Some sites promise increased libido and reduced stomach fat.

Male Excel’s ads on Google, for example, say TRT “improves mood” and “restores vitality.” And its site says testosterone treatment will provide “muscular definition,” “weight loss,” “explosive drive,” “deeper sleep,” and “restored energy” above a link to a free assessment on its online telehealth platform. Craig Larsen, the company’s CEO, did not reply to several attempts to contact him by phone and email.

Both Male Excel and Hone Health are among the sites that pitch to military veterans. Hone Health included a video of a veteran who said he was refused testosterone treatment by a Department of Veterans Affairs hospital.

Saad Alam, CEO and co-founder of Hone, said that his company is what he called a “conservative” player in the market. He said that Hone prescribes only to men who are hypogonadal and tests men every 90 days, unlike other companies that operate telehealth websites as what he called a “cash grab.”

“I agree that patients should be treated by their doctors. But the U.S. medical system isn’t at a point where it can service men who have this problem, and some endocrinologists would rather treat patients who are higher-profit,” Hone said. “That’s why people are coming to us.”

One popular form of TRT is injectable testosterone cypionate. According to the Medicare average sales price database, it costs $0.027 per milligram. Online purveyors who sell the drug directly to consumers in 200 mg/mL vials for an average price of $129 per month are charging the equivalent of $1.55 per mg — a markup of more than 50 times the average Medicare price.

According to a 2022 study, the TRT telehealth websites create a way to circumvent doctors who refuse to prescribe the hormone. In that study, Justin Dubin, a urologist at the Memorial Healthcare System in Florida, posed as an online mystery shopper. He reported an above-normal testosterone level, and stated his desire to start a family, even though such therapy can curb sperm production. But six of the seven unnamed online TRT clinics prescribed him testosterone via a medical professional.

“And that’s concerning,” Dubin said. “Telemedicine helps men with hypogonadism who might be too embarrassed to discuss erectile dysfunction. But we need to do a better job of understanding the appropriateness of care.”

Still, while the FDA doesn’t allow off-label marketing, it does allow such off-label prescriptions.

 

Off-label use of testosterone replacement has become especially commonplace among veterans. And among male service members who received TRT in 2017, fewer than half met the clinical practice guidelines, according to a report by the U.S. military.

Phil Palmer, a 41-year-old Marine Corps veteran who lives outside Charleston, South Carolina, said he pays out-of-pocket for bloodwork and prescriptions for a pellet skin-implant form of testosterone and for clomiphene, a drug that can help counter the male infertility that is a side effect of testosterone treatment. He said the treatment appeals to him and other veterans dealing with the aftermath of military service.

“The environment we served in and stress levels have a lot to do with it,” Palmer said. “We were exposed to burn pits. The military doesn’t teach you to eat well — we ate a lot of processed food.”

In medical settings, TRT can speed recovery of soldiers who have bone density issues or spinal cord injuries, said Mark Peterson, a professor of physical medicine and rehabilitation at the University of Michigan Medical School. But, he said, “for men in the normal-T range, using an online prescription to buy testosterone to reduce stomach fat can be counterproductive.”

Those who use it also risk having to take testosterone medication indefinitely, because TRT can cause the body to cease its own production of the hormone.

Palmer, who founded a nonprofit that helps veterans heal through exercise, nutrition, and mentorship, said the medication has been helpful for him but urges fellow veterans to seek care from their doctors rather than what he called “bro science” websites touting testosterone.

“It’s not a magic pill,” he said.

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©2024 KFF Health News. Distributed by Tribune Content Agency, LLC.

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