Officials under President Trump are looking to simplify the process for men to obtain prescriptions for testosterone. This represents a notable shift in the ongoing conversation about the advantages and potential risks of this hormone, which plays a significant role in aspects like sex drive and mood.
This initiative, led by Health Secretary Robert F. Kennedy Jr. and other prominent figures, seems to echo sentiments from various online influencers and podcasters. Many health advocates are promoting testosterone as a way to enhance muscle strength and energy levels. Recently, Defense Secretary Pete Hegseth announced that the military plans to start testing troops for low testosterone and to provide the hormone to help improve their performance.
However, the idea that testosterone is a universal solution for vitality and strength isn’t firmly backed by scientific evidence. Medical professionals point out that new research over the past decade does support some benefits of testosterone concerning sexual health, but also reassures regarding its cardiovascular impacts.
“For years, many providers believed there were serious risks, making them hesitant to assess testosterone levels or suggest therapy,” noted Dr. Justin Dubin, a urologist at Baptist Health Miami Cancer Institute.
Last year, the Food and Drug Administration lifted a prominent safety warning about heart-related risks associated with testosterone products, citing new data showing no significant increase in such problems.
In addition, the FDA recently proposed changes to prescribing guidelines to facilitate the use of testosterone to treat age-related symptoms, including low libido and erectile dysfunction. Currently, the hormone is mainly approved for cases of abnormally low testosterone caused by severe medical issues.
Yet, practitioners argue that the patients who truly qualify make up only a small fraction of those seeking assistance.
“Most of the men we see are simply ordinary individuals experiencing symptoms that significantly impact their quality of life,” expressed Dr. Helen Bernie, a urologist and director of sexual health at Indiana University.
Evolution of Testosterone Use
Testosterone was first approved for treatment in the 1950s for hypogonadism, a condition marked by low testosterone due to medical issues affecting the testes or other organs.
As men naturally age, testosterone levels decrease, influencing sexual function, mood, bone density, and more. The complexities of diagnosing and treating these age-related issues are still hotly debated among researchers.
“These symptoms can overlap significantly with typical signs of aging, leading to a high likelihood of misdiagnosis, which fuels the ongoing controversy,” Dr. Shalender Bhasin from Harvard Medical School pointed out. Bhasin believes the growing willingness to prescribe testosterone reflects an increased recognition of men’s sexual health challenges, particularly after Viagra’s introduction in the 1990s.
Bhasin has contributed to the Endocrine Society’s current guidelines, suggesting that men displaying documented symptoms and verified low hormone levels should consider testosterone therapy. A recent Michigan study revealed that only 12% of men receiving prescriptions actually met these suggested criteria.
Concerns Over Overprescribing
The risk of excessive testosterone prescriptions prompted tighter regulations in recent years.
In the early 2010s, pharmaceutical companies spent heavily on advertisements for gels and patches that claimed to remedy “low T,” highlighting a plethora of symptoms ranging from fatigue to weight gain. By 2013, testosterone products generated over $2 billion in annual sales despite lacking FDA approval for numerous described conditions. Doctors do have the authority to prescribe medications for unapproved uses, and many men still opt for testosterone believing it enhances their energy and mood.
However, in 2015, the FDA required companies to clarify that their products weren’t sanctioned for general issues and mandated a boxed warning regarding potential heart risks.
New Research and FDA Revisions
The FDA now indicates that updated research warrants loosening these restrictions.
A recent FDA-funded study, which followed 5,000 men with cardiovascular history, administered testosterone gel to half of the participants while the other half received a placebo. Over two years, both groups showed similar rates of heart attack and related issues.
A series of NIH studies also underscored the advantages of testosterone therapy. Findings from nearly 800 older men indicated improvements in erectile dysfunction, libido, and related sexual metrics, with minor effects on mood. Conversely, there was little enhancement in areas like fatigue or overall well-being.
While these recent studies are the largest to date, Bhasin emphasizes the need for further research to explore long-term effects.
“The FDA’s modifications to the labeling are certainly a significant advancement, but there’s still much to be done for a clearer understanding of both safety and effectiveness,” he added. The Endocrine Society has suggested that studies spanning 15 to 20 years would be essential to evaluate slowly evolving conditions like prostate cancer, particularly relevant when considering testosterone prescriptions.
Caution for Certain Patients
Experts agree that men planning on fatherhood should avoid testosterone treatments, as these can disrupt the body’s natural hormone production.
“Taking testosterone can halt the brain’s signals to the testicles, which might stop sperm production,” Dubin said. “This can lead to fertility issues.”
Most medical guidelines also advise caution for men with a history of prostate cancer or those at risk, given concerns about whether hormone therapy may accelerate tumor growth. However, guidelines are poised for change; the FDA is suggesting that only men with metastatic prostate cancer should steer clear of testosterone therapy.
Beware of Online Claims
Men should be wary of online supplements advertising testosterone boosts, as many lack FDA approval and likely do not yield results.
FDA-approved testosterone therapies come in various forms, with gels and pills usually requiring daily use. Injections and patches can last from weeks to several months.
Many of these medications can also be accessed through telehealth services, but there are potential risks involved with that route.
In 2022, Dubin conducted a study revealing that only 1 in 7 online pharmacies asked essential screening questions, such as whether men were considering having children. Additionally, most had no criteria regarding what constitutes low testosterone levels.
