Michael Scaturro | KFF Health News (TNS)
Online stores started popping up in the telehealth boom during COVID-19, claiming that testosterone can cure all of men's age-related illnesses despite the FDA's ban on off-label advertising. FDA rules issued years ago restricting such “low testosterone” advertising.
Testosterone telemedicine websites are using ads on Google, Facebook, and other places to promise a quick solution for tiredness and low sex drive in men. However, doctors say there isn't enough evidence for that, and the problems that testosterone is being advertised as a cure for are probably caused by chronic medical conditions, poor diet, or not being physically active. In fact, doctors urge caution— and the FDA recommends that all testosterone supplements carry a warning that they may increase the risk of heart attack and stroke.
Some men do have valid medical reasons to be treated with testosterone. The hormone has been used as medicine for many years, and today it's used by men with hypogonadism, some transgender men who use it as part of transitioning physically, and, in some cases, women with menopausal symptoms. It has also been used for many years by bodybuilders and athletes to increase strength.
However, online stores can exaggerate the idea of what some people call “male menopause,” or even “manopause,” to sell expensive testosterone-boosting injections, and sometimes they ignore safety guidelines that are supposed to stop healthy men from using the hormone. Some of the websites target military veterans.
“I have seen ads online that do cross the line,” said Steven Nissen, a doctor who is the chief academic officer for the Heart, Vascular, and Thoracic Institute at the Cleveland Clinic. “For mood and low energy, prescribing testosterone provides little to no benefit. They are promoting testosterone for indications that are not on the label.”
Online health websites almost all mention a one study study from 2002 by scientists at New England Research Institutes who found that testosterone levels drop by 1% each year in men over 40. Stefan Schlatt, director of the Center for Reproductive Medicine and Andrology at the University of Muenster in Germany, said the data behind the statistic included older men in deteriorating health whose levels declined because of illnesses.
“Healthy men do not show a drop,” he said.
That 2002 study led to a flood of “low-T” ads on U.S. television, and those ads were later banned by the FDA in a 2015 ruling for exaggerating the low-T trend to scare men into buying drugs. According to another study, the market for testosterone supplements stood at $1.85 billion in 2023.
The flood of ads “has fueled demand for a largely uninsured product, allowing for high markups,” said Geoffrey Joyce, director of health policy at the USC Schaeffer Center for Health Policy & Economics and a research associate at the National Bureau of Economic Research. “The primary driver is manufactured demand.”
Barbara Mintzes, a professor of evidence-based pharmaceutical policy at the University of Sydney’s Charles Perkins Centre in Australia, said low testosterone should really be seen as a sign of a condition that needs to be treated. She said diabetes, heart disease, high blood pressure, obesity, exposure to harmful substances such as PFAS, and anxiety can all lower levels of testosterone.
A number of websites examined by KFF Health News present themselves as news and fitness magazines, with ads woven into articles directing readers to purchase testosterone replacement therapy, abbreviated as TRT. The prices for TRT on these sites range from $120 to $135 per month, not including initial mail-back blood tests for about $60. Some sites promise increased sex drive and reduced belly fat.
For instance, Male Excel’s ads on Google tout TRT as a way to “enhance mood” and “regain energy.” The company's website claims that testosterone treatment will lead to “increased muscle tone,” “weight reduction,” “intense motivation,” “improved sleep,” and “renewed energy” alongside a link to a free evaluation on its online telehealth platform. Craig Larsen, the company’s CEO, did not respond to multiple attempts to reach him by phone and email.
Both Male Excel and Hone Health are some of the websites that target military veterans. Hone Health included a video featuring a veteran who said he was denied testosterone treatment by a Department of Veterans Affairs hospital.
Saad Alam, CEO and co-founder of Hone, described his company as a “conservative” player in the market. He stated that Hone only prescribes to men with low levels of testosterone and tests men every 90 days, unlike other companies that operate telehealth websites as what he termed a “cash grab.”
“I believe that patients should be treated by their doctors. However, the U.S. medical system is not currently equipped to care for men with this issue, and some endocrinologists would rather treat patients who are more profitable,” Hone said. “That’s why people are coming to us.”
One popular type of TRT is injectable testosterone cypionate. According to the Medicare average sales price database, it costs $0.027 per milligram. Online sellers who directly sell the drug to consumers in 200 mg/mL vials at 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.
As per a 2022 study, the TRT telehealth websites provide a way to bypass doctors who refuse to prescribe the hormone. In that study, Justin Dubin, a urologist at the Memorial Healthcare System in Florida, acted as an online secret shopper. He reported above-normal testosterone levels and expressed his desire to start a family, even though such therapy can reduce sperm production. However, six of the seven unnamed online TRT clinics prescribed testosterone to him via a medical professional.
“And that’s troubling,” Dubin said. “Telemedicine assists 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.”
Nevertheless, while the FDA doesn’t permit off-label marketing, it does allow such off-label prescriptions.
The non-approved use of testosterone replacement has become particularly common 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 resides 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 medication that can aid in addressing the male infertility that is a secondary effect of testosterone therapy. He stated that the treatment is appealing to him and other former military members who are coping with the consequences of their service.
“The conditions we served in and the pressure levels play a significant role,” Palmer said. “We were exposed to burn pits. The military doesn’t teach you to eat well — we consumed a lot of processed food.”
In medical environments, TRT can accelerate the recovery of soldiers who have bone density problems or spinal cord injuries, as stated by Mark Peterson, a professor of physical medicine and rehabilitation at the University of Michigan Medical School. However, he mentioned, “for men with normal-T levels, using an online prescription to purchase testosterone for reducing stomach fat can be counterproductive.”
Those who use it also risk having to take testosterone medication forever, as TRT can cause the body to stop producing the hormone on its own.
Palmer, who established a non-profit organization that aids veterans in healing through exercise, nutrition, and mentorship, stated that the medication has been beneficial for him but advises fellow veterans to seek treatment from their physicians rather than what he referred to as “bro science” websites promoting testosterone.
“It’s not a magic pill,” he said.
(KFF Health News is a national newsroom that produces comprehensive journalism about health matters and is one of the key operational programs of KFF — the independent source for health policy research, polling and journalism.)
©2024 KFF Health News. Distributed by Tribune Content Agency, LLC.
