It’s time to end America’s testosterone paranoia

Patients
Silhouette of a very muscular man

For over 30 years, the US has clung to an outdated and misguided war on testosterone, lumping it in with the anabolic steroids that come under the 1990 Anabolic Steroid Control Act.

This knee-jerk reaction to 1980s doping scandals has left millions of men at risk from suffering from Testosterone Deficiency Syndrome (TDS), which remains underdiagnosed and untreated.

The result? A public health crisis that’s been quietly ignored while European countries move forward, recognising testosterone’s vital role in men’s health.

Dispelling the myths

Let’s be clear: testosterone isn’t just for bodybuilders and athletes. It’s essential for the health and well-being of millions of men, particularly those over 45, 40% of whom suffer from TDS. This isn’t about vanity; it’s about addressing a serious medical condition linked to obesity, Type 2 diabetes, and even cardiovascular disease. Yet, the FDA has been content to sit on its hands in terms of changing the ban, allowing a flawed 2014 study to continue to fuel baseless fears about testosterone therapy.

The science is irrefutable. Recent studies, including the groundbreaking 2023 TRAVERSE trial, have obliterated the myths surrounding testosterone therapy, showing no increased cardiovascular risks. In fact, testosterone therapy can significantly improve health outcomes for men with TDS – reducing the risk of diabetes by as much as 42%, as well as heart disease, and more. So, why is the FDA still dragging its feet? The answer lies in outdated thinking and a reluctance to admit that the old approach was wrong.

The time for change is now. The FDA’s refusal to update its stance on testosterone is not just bureaucratic inertia; it’s a failure to protect public health. American men deserve better. They deserve the right to safe, effective treatment options that can dramatically improve their quality of life. And they deserve a healthcare system that treats testosterone therapy as what it is: a crucial tool in managing men’s health, not a relic of steroid hysteria.

Male health, ageing, and TRT

The role of ageing in TDS means that its prevalence will increase as the population ages, particularly in developed nations where the proportion of people over 65 exceeds 20%. Some have argued that as TDS is linked to ageing it should not be treated; however, 2020 research from Androgens: Clinical Research and Therapeutics argues that those who suffer from TDS linked to age can benefit in just the same way as other patients from testosterone replacement therapy (TRT).

The paper found the FDA made an artificial distinction between diagnoses where TRT treatment was warranted and others where the underlying diagnosis is unknown, but age related, and treatment is unwarranted. It concluded that the action by the FDA is not based on scientific or clinical evidence.

Chronic health conditions such as diabetes, cardiovascular diseases, and metabolic syndrome are also associated with lower testosterone levels. Low testosterone levels are linked to depression, as well, and treatment with TRT has been demonstrated to improve the depressive symptoms.

The hormone also plays a crucial role in maintaining bone density, muscle mass, fat distribution, libido, and mood, so its deficiency can significantly impact overall health. Regular testosterone testing after the age of 40 is essential, as it is a cost-effective and insightful health marker – arguably more so than frequently tested blood markers like cholesterol.

The FDA’s ban has hindered the development of a widespread testing regime, leading to underdiagnosis and undertreatment of testosterone deficiency, affecting men’s health and quality of life.

The European example

TRT is an effective and affordable way to improve overall health. TRT mimics the body’s natural testosterone production, aligning closely with normal hormone levels and avoiding many of the side effects traditionally associated with hormone therapy. Unfortunately, the 2014 US study that suggested potential cardiac risks associated with testosterone therapy has perpetuated misconceptions about its safety. Although this study has since been debunked, the damage to testosterone’s reputation persists.

In contrast, European regulators have approached testosterone therapy with a more scientific mindset, analysing the same data without concluding that TRT is dangerous. A large, double-blind clinical trial called TRAVERSE, conducted in 2023 with over 5,000 participants, found no risks to cardiovascular health. Despite these findings, the FDA has yet to change its stance on testosterone therapy.

Biotech advances have made testosterone administration safer and more versatile, with many options.

If current lifestyle and environmental trends persist, testosterone levels will continue to decline. Rising obesity rates, sedentary behaviour, and ongoing exposure to endocrine-disrupting chemicals suggest that this trend won’t reverse without significant public health interventions.

Medical societies must play a more active role in updating clinicians and patients on the latest research. Testosterone therapy can not only improve patients' metabolic health, but also help reduce overall healthcare costs by preventing downstream health issues. It is time to rethink the US approach to testosterone and ensure that men receive the care they deserve.

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Shalin Shah
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Shalin Shah