GoKawiilIs testosterone the next miracle drug? That seemed to be the consensus of an expert panel convened by the US Food and Drug Administration (FDA) in December. It argued for major changes in policy that would expand access to the hormone for people with a range of conditions. Committee members called testosterone replacement “a cornerstone of preventive health” and “a multibillion-dollar preventive-care opportunity”.
Testosterone is already available in the United States for people who have low levels of the hormone owing to a known medical issue, such as testicular damage. But evidence is growing that more men — and women — might benefit from the hormone, which is delivered through injections, patches, subcutaneous implants or gels. (This article uses ‘men’ and ‘women’ to reflect the language used by the panels and studies cited, while recognizing that trans, non-binary and intersex people are also affected by this issue.)
The panel’s recommendations intensify a debate that has been brewing about who might benefit from the treatment. Some clinicians say that most men with low testosterone, especially young ones with no medical issue contributing to the problem, don’t need supplemental treatment at all and should be able to raise their testosterone levels by adopting a healthier lifestyle and losing weight. Others argue that men with low testosterone who have symptoms such as low libido, fatigue and irritability could gain from the therapy.
The misunderstood sex chromosome: how X affects your health
More-enthusiastic proponents, including many members of the FDA panel at the December meeting, take a third view: that all cis men should be tested, and those with low testosterone levels should be treated even if they have no symptoms. “You could make a very strong argument that having a normal testosterone level is important for health and prevention of illness,” says Abraham Morgentaler, a urologist at Harvard Medical School in Boston, Massachusetts, who took part in the December panel.
Morgentaler and other panellists stressed at the meeting that testosterone is not just a ‘lifestyle drug’ that men take to build muscle and feel good. Yet it is increasingly being marketed that way. Podcasters such as Joe Rogan and his guests have sung the hormone’s praises. And scores of testosterone clinics are popping up around the world1, promising fitter bodies and a boost in energy levels to people who might not even have low testosterone to begin with.
At high doses, testosterone use potentially comes with risks ranging from infertility to increased mortality. The drug is currently classified as a controlled substance with potential for abuse in the United States and several other countries, owing in part to doping scandals in the 1990s and 2000s. That classification is worth reconsidering according to statements made by FDA commissioner Marty Makary, who also voiced his enthusiasm for testosterone at the December panel.
So what is the evidence for the safety and benefits of testosterone replacement?
Safety record
Testosterone’s reputation has had its ups and downs since the hormone was first synthesized in the 1930s. After an initial golden period, in which it was described as “one of the most potent drugs recently introduced to medicine”2, the therapy fell out of favour for fear that it could cause cancer. This idea originated from the work of urologist Charles Huggins who, in 1941, found that prostate cancer depends on testosterone and that lowering the hormone levels caused tumours to shrink3. It was a groundbreaking discovery for which he was awarded a share in the Nobel Prize in Physiology or Medicine in 1966.
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