The Wild West of Online Testosterone Prescribing

Online testosterone peddlers are facing uncertainty as federal officials map the future of telemedicine. At stake is whether they'll be able to continue prescribing testosterone therapy to patients without ever seeing them in person, a pandemic-era freedom that allows men to avoid being seen strolling into "low T" clinics -- but one that has also raised concerns about sketchy prescribing practices.

There's evidence that a number of online testosterone clinics have inappropriately prescribed the hormone via telemedicine to men who don't need it. A recent study in JAMA Internal Medicine reported that six out of seven direct-to-consumer, online-only clinics prescribed testosterone to an undercover urologist, even though he had normal levels of the male hormone and didn't warrant treatment under American Urological Association and Endocrine Society guidelines.

Like several of his colleagues, Alexander Pastuszak, MD, PhD, a urologist at the University of Utah in Salt Lake City, told MedPage Today that he's disturbed by signs that online clinics are overprescribing testosterone to men seeking relief from fatigue and lack of libido.

"From a clinical standpoint and a patient-management standpoint, they're definitely not doing the right thing," Pastuszak said. "You need to balance the ability of patients to access these medications with the reality that [the medications] can have damaging side effects."

A more existential threat to these telehealth testosterone purveyors are pending changes to federal telemedicine freedoms extended during the pandemic that allowed providers to prescribe testosterone and other controlled medications without any office visits.

Extending the 'Low T' Craze

The low-T craze began in the 2000s as marketing campaigns urged men to consider testosterone therapy to restore their vitality and virility.

In some cases, men went to their regular physicians for help and found it: A 2018 study examining commercial insurance data found that the percentage of men age 30 and older who took testosterone grew from 0.52% in 2002 to 3.2% in 2013, "mostly in men without a clear indication." The level later dropped to 1.67% in 2016 amid concerns about cardiac risk from testosterone use.

Other men bypassed their own physicians and sought testosterone from low-T clinics that popped up across the country. These clinics hawk the hormone to men who believe their levels are too low, not as a component of gender-transition therapy.

Prior to the pandemic, prescribers had to see patients in person before prescribing testosterone, a Schedule III "controlled" drug with limited access due to its potential for abuse as a muscle-building steroid. But in March 2020, the federal government responded to pandemic shutdowns by allowing practitioners to prescribe controlled medicines without an initial in-person visit.

Several men's health sites responded to their newfound freedom by offering testosterone therapy via telemedicine with no office visits required. TRT Nation, for example, says it provides prescriptions via telemedicine in 46 states and aims "to provide exceptional healthcare while offering the patient the right to quality prescription medication without the hassle of visiting a doctors [sic] office." A site called RegenX Health touts that it has "no waiting rooms" and says any man can become a "member" if he has a valid driver's license and credit card, knows his blood pressure, and has seen a primary physician within the past 3 years.

Urologist Goes Undercover, Gets Overtreated

Are the online-only clinics following standards of care? Justin Dubin, MD, a urologist now at Memorial Healthcare System in Aventura, Florida, decided to find out. In 2022, he became a "secret shopper" and approached seven online testosterone clinics that served all 50 states.

"I identified myself as a 34-year-old man with symptoms of low testosterone -- low energy and erectile dysfunction," Dubin told MedPage Today. "I got the required bloodwork, went to the initial telemedicine consultations, and listened to their assessment of me and what they recommended."

The symptoms were fake, but Dubin's age and blood test results were real. They showed his actual testosterone levels: 675 ng/dL total testosterone and 10 pg/mL free testosterone. Normal levels are 264 to 916 ng/dL and 8.7 to 25 pg/mL, respectively, according to the 2022 study in JAMA Internal Medicine that reported the results of Dubin's investigation.

Dubin would not qualify for testosterone therapy under medical society guidelines. The Endocrine Society only recommends hormone treatment for testosterone deficiency in men if they show "unequivocally and consistently low serum T concentrations," and the American Urological Association says total testosterone levels are only low if they're under 300 ng/dL based on two early-morning tests.

Despite the guidelines, six of the seven clinics still offered him testosterone therapy -- never mind the potential harms of therapy, its high cost, and the likelihood that treatment wouldn't provide any benefits.

According to Dubin's report, one clinic said its goal for its patients is over 800 ng/dL total testosterone, another said its goal is a level of 1,000-1,500 ng/dL, while two others put their total testosterone goals at 1,000-1,200 ng/dL. Another two clinics only identified their goal levels of free testosterone: 25-35 pg/mL and over 20 pg/mL.

The sole clinic that declined to offer testosterone to Dubin defined abnormal total testosterone levels as ones below 450 ng/dL, meaning he didn't qualify for treatment under its policies.

Online Clinics Keep Mum About Risks

Four clinics failed to ask Dubin about recent cardiovascular events, even though the FDA has required testosterone labels to include warnings about cardiac risk since 2015. There's been an intense debate in recent years about possible links between testosterone therapy and cardiac problems, and the Endocrine Society recommends against testosterone therapy in men with heart attacks or strokes within the past 6 months.

Only three clinics discussed possible effects on fertility, although the Endocrine Society recommends against testosterone treatment in men who hope to soon have children.

"Testosterone can suppress male fertility, so much so that it has been studied as a male contraceptive agent," study coauthor Joshua Halpern, MD, MS, a urologist at Northwestern University in Chicago, told MedPage Today. "From time to time, we certainly see a man who comes in on testosterone therapy who is experiencing infertility. Either nobody counseled them or they didn't have a great understanding that going on testosterone would suppress their sperm production to the point of having no sperm at all."

Dubin declined to identify which online testosterone providers he contacted. MedPage Today reached out to several online testosterone clinics for comment about their telemedicine-only policies. Only one responded: Hone Health. In an interview, CEO and co-founder Saad Alam said the company follows American Urological Association guidelines.

Would providers at Hone Health treat someone like Dubin with a normal testosterone level?

"Patients would typically not get started on treatment with an initial testosterone level of 675 ng/dL unless they were already coming to the practice on treatment," Alam said. "If a physician prescribes testosterone to a new patient who's above 400 ng/dL, the physician receives an alert to double check this is appropriate." Then, he said, a medical director reviews the case.

"Our physicians always discuss side effects, both common and rare, with their patients," Alam added.

More Reasons for Caution

Low-T clinics often prescribe drug cocktails that boost testosterone, causing some patients to reach extraordinarily high levels of 2,000 ng/dL or more, according to Bradley Anawalt, MD, a urologist at the University of Washington in Seattle.

Indeed, Dubin told MedPage Today that all seven clinics he contacted tried to sell him other testosterone-boosting products, such as human chorionic gonadotropin. Clinics also offered a variety of other therapies including oxytocin and kisspeptin, a pair of reproductive hormones.

According to Anawalt, ultra-high levels of testosterone seem certain to boost the risk of adverse effects from therapy. Adverse effects from testosterone therapy can include erectile dysfunction, hot flashes, depression, tender breasts, and loss of libido, according to Harvard Medical School. Testosterone therapy can also cause breast growth and shrunken testicles. However, physicians can prescribe medications to reduce adverse effects.

A failure to follow medical guidelines could spell trouble for online testosterone sellers if prosecutors are willing to act. In New York, the attorney general's office in 2018 successfully pressured Ageless Men's Health, a national chain of low-T clinics, to stop ignoring medical society treatment guidelines. The Ageless chain now boasts 57 locations, including nine in Arizona, five in Tennessee, six in Utah, and four in Mississippi.

In a 2023 editorial, Steven Woloshin, MD, MS, of Dartmouth Medical School in Hanover, New Hampshire, and Consumer Reports investigative reporter Lisa Gill called on state medical boards and other regulators to step in to monitor online testosterone clinics. "Consumers need to be aware of the potential for bad care, and regulators need to do more to protect them," they wrote.

It's not clear if online testosterone clinics are more -- or less -- likely to follow guidelines than their brick-and-mortar clinic counterparts. Still, the online providers do appear to stand out from their colleagues in one way: how much they charge.

Low-T clinics often refuse to take insurance and forbid patients from filling their hormone prescriptions at outside pharmacies. A 2022 analysis in the Journal of Sexual Medicine found that the cost of 12 months of intramuscular testosterone ranged from $1,586 to $4,200 at three online clinics -- TRT Nation, RegenX Health, and Hone Health. By comparison, an in-person clinic charged $1,333 without insurance and $134 to $781 with insurance.

Another five online testosterone clinics weren't included in the 2022 analysis due to "lack of transparency on their websites."

In a 2022 paper in the International Journal of Impotence Research, Dubin, Halpern, and a colleague highlighted the importance of in-person examinations -- at least initially -- for men who seek testosterone therapy. In-person visits allow providers to check for comorbidities such as heart disease and Peyronie's disease, they wrote. The authors added that "we recommend that the initial evaluation of men with suspected TD [testosterone deficiency] should be performed in-person and by the prescribing physician, if possible."

That was the requirement for controlled substances like testosterone under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, which was created to regulate online internet prescriptions with oversight by the Drug Enforcement Administration (DEA). It ensured that patients would have at least one in-person medical evaluation before getting a prescription managed via telehealth.

Under Pressure, Feds Punt on Telemedicine -- For Now

The DEA had announced plans effective May 2023 to lift pandemic-era telemedicine freedoms, so that clinicians would once again be required to see patients in person before approving refills for testosterone and other controlled substances. That move appeared to be triggered more by the end of the COVID-19 public health emergency than by any particular problematic prescribing practices during the pandemic.

Still, the agency ran into a buzz saw of protest. It received more than 35,000 comments in response to the proposed new rules, and a text search showed that about 6,400 of them mentioned testosterone specifically.

In particular, those objections came from members of the transgender community who warned that trans men in remote areas could lose access to testosterone. Last year, Senators Ed Markey (D-Mass.) and Elizabeth Warren (D-Mass.), urged federal officials to either lift some restrictions on testosterone prescriptions or remove them entirely in order to support trans men.

In May 2023, federal officials hastily backtracked on the planned changes for controlled substance teleprescribing.

According to the DEA and the Substance Abuse and Mental Health Services Administration, providers can continue to prescribe testosterone and other controlled medications online without in-person visits through Nov. 11, 2023. And providers who already have established relationships with patients as of Nov. 11 will be able to take advantage of the telemedicine flexibilities until Nov. 11, 2024.

Atop that uncertainty about their future, online testosterone clinics may face financial strain even if they're allowed to continue to prescribe without in-person visits, said Pastuszak, the University of Utah urologist. In 2019, he co-founded an online men's health clinic that followed standards of care. But the company failed to thrive and stopped providing clinical services in 2022, he said.

"It's a very difficult business to get to scale and maintain," Pastuszak said. "The acquisition of patients is really expensive, and patients are very fickle unless you are in-network with insurance providers. On a whim, they'll decide they're no longer going to pay for their own healthcare. It's really hard to run a business based around that unless you're really at scale. And getting to scale is a real challenge."

Online low-T clinics that arose to take advantage of telemedicine freedoms will face tough times if the flexibilities vanish, Evan M. Hellman, JD, a New York City attorney who specializes in digital health, told MedPage Today. "Their business," he said, "will need to fundamentally change."

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