"Unveiling the Controversial World of Testosterone Websites: Defying FDA Regulations to Promote Off-Label Use"

Most healthy men produce sufficient testosterone as they age. Yet online ads and telehealth sites are promoting testosterone drugs with flawed promises of boosting libido and busting stomach fat.

"Unveiling the Controversial World of Testosterone Websites: Defying FDA Regulations to Promote Off-Label Use"
entertainment
16 Mar 2024, 03:17 PM
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Amid the telehealth boom of the COVID-19 pandemic, online stores have emerged promoting testosterone as a panacea for age-related ailments in men. This is in defiance of FDA regulations established years ago that restrict advertising for "low testosterone" treatments.

Advertisements on various platforms like Google and Facebook from testosterone telemedicine websites claim to offer a quick remedy for fatigue and diminished libido in men. However, medical professionals point out the lack of evidence supporting these claims. The feelings of midlife fatigue that testosterone is purported to address are more likely linked to underlying health conditions, poor dietary choices, or a sedentary lifestyle. In fact, physicians advise caution, and the FDA mandates that all testosterone supplements carry a warning about the potential increased risk of heart attacks and strokes.

While there are legitimate medical reasons to prescribe testosterone for certain individuals, such as those with hypogonadism, transgender men undergoing physical transition, and occasionally women experiencing menopausal symptoms, the hormone has been used for years by bodybuilders and athletes seeking to enhance their strength.

Questionable Marketing Tactics Used by Online Dispensaries

Online dispensaries are leveraging the concept of "male menopause," sometimes dubbed "manopause," to promote the sales of lucrative testosterone-boosting injectables. In this pursuit, they often disregard safety precautions that are in place to discourage healthy men from using such hormones. Notably, certain websites are specifically targeting military veterans.

"I have come across online advertisements that definitely cross ethical boundaries," stated Steven Nissen, a physician and the chief academic officer at the Cleveland Clinic's Heart, Vascular, and Thoracic Institute. "Prescribing testosterone for mood swings and low energy yields minimal to no actual benefits. These platforms are advocating testosterone usage for conditions that are not approved."

Almost all testosterone telehealth websites refer to a study from 2002 conducted by scientists at New England Research Institutes. The study suggested that testosterone levels decrease by 1% annually in men over 40. However, Stefan Schlatt, the director of the Center for Reproductive Medicine and Andrology at the University of Muenster in Germany, pointed out that the data in the research included elderly men in poor health, whose levels dropped due to underlying illnesses.

"Men in good health do not exhibit such declines," Schlatt emphasized.

The 2002 study triggered a wave of "low-T" advertisements on American television screens, which were eventually prohibited by the FDA in 2015. The FDA accused the pharmaceutical sector of overstating the low-T trend to intimidate men into purchasing medications. As per another report, the market for testosterone supplements was valued at $1.85 billion in 2023.

The deluge 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 toxic chemicals like PFAS and stress can all reduce testosterone levels.

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 cater to military veterans. Hone Health featured a video of a veteran sharing his experience of being denied testosterone treatment by a Department of Veterans Affairs hospital.

CEO and co-founder of Hone, Saad Alam, described his company as a "conservative" player in the market. He mentioned that Hone only prescribes to men with hypogonadism, conducting tests every 90 days. Alam criticized other telehealth companies, labeling them as a "cash grab."

"While I believe patients should be under the care of their physicians, the U.S. medical system currently falls short in addressing the needs of men with this condition. Some endocrinologists prioritize treating higher-profit patients," Alam explained. "This is why individuals are turning to us for help."

One common form of Testosterone Replacement Therapy (TRT) is injectable testosterone cypionate. Medicare's average sales price database shows it costs $0.027 per milligram. However, online vendors sell the drug in 200 mg/mL vials directly to consumers for an average price of $129 per month, equivalent to $1.55 per mg — marking up the price by over 50 times the average Medicare cost.

Study Finds TRT Telehealth Websites Circumvent Traditional Prescription Processes

A recent study conducted in 2022 revealed that TRT telehealth websites offer a way to bypass doctors who are hesitant to prescribe testosterone replacement therapy. Dr. Justin Dubin, a urologist at the Memorial Healthcare System in Florida, conducted the study by posing as an online mystery shopper. Despite expressing a desire to start a family, which can be hindered by reduced sperm production due to such therapy, six out of seven online TRT clinics prescribed testosterone to him through a medical professional.

"This raises concerns," Dr. Dubin commented. "While telemedicine can assist men with hypogonadism who may feel uncomfortable discussing erectile dysfunction in person, we must improve our understanding of the appropriateness of care."

Although the FDA prohibits off-label marketing, it does permit off-label prescriptions, leading to a rise in off-label use of testosterone replacement therapy, particularly among veterans. A report by the U.S. military indicated that in 2017, less than half of male service members who received TRT met the clinical practice guidelines.

Phil Palmer, a 41-year-old Marine Corps veteran residing near Charleston, South Carolina, shared that he personally covers the costs of bloodwork and prescriptions for a pellet skin-implant form of testosterone and clomiphene, a drug that can help mitigate the male infertility resulting from testosterone treatment. Palmer explained that this treatment option is appealing to him and other veterans grappling with the consequences of military service.

"The conditions we were exposed to and the stress levels play a significant role," Palmer stated. "The military does not prioritize teaching proper nutrition — we consumed a lot of processed foods."

In the field of medicine, Testosterone Replacement Therapy (TRT) can aid in the recovery of soldiers dealing with bone density issues or spinal cord injuries, as stated by Mark Peterson, a professor of physical medicine and rehabilitation at the University of Michigan Medical School. However, Peterson warns that for men with normal testosterone levels, seeking online prescriptions for testosterone to reduce stomach fat may have counterproductive effects.

Individuals who opt for TRT also face the potential of needing to take testosterone medication indefinitely, as the therapy can lead to the body halting its own production of the hormone.

Palmer, the founder of a nonprofit organization dedicated to aiding veterans through exercise, nutrition, and mentorship, shared that while the medication has been beneficial for him, he advises fellow veterans to consult with their healthcare providers rather than relying on what he referred to as "bro science" websites promoting testosterone.

"It's not a magic pill," he emphasized.

KFF Health News, formerly known as Kaiser Health News (KHN), is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.