It s just another futile search for the Fountain of Youth. In recent years, the idea that low levels of testosterone (T) were responsible for multiple afflictions in older males has spurred a cottage industry in testosterone replacement therapy in both traditional pharmaceutical and supplement companies.
On some level it makes at least a little sense. As men age, their production of testosterone does decline. But is this something that should be fixed, and if so, how? There is not yet a definitive answer to this question.
But an equally relevant question is whether men who have testosterone levels within normal levels should be taking drugs to boost them.
The FDA just made it clear where they stand: There is no bona fide use of testosterone replacement except in specific, rare instances hypogonadism (low testosterone) caused by testicular and pituitary diseases.
Wisely, the expert panel of the Bone Reproductive and Urologic Drugs Advisory Committee, and the Drug Safety and Risk Management Advisory Committee voted 20-1 to limit off-label use of T supplements by changing labels on the drugs.
And, by the same vote, the committees required that clinical trials specifically to determine adverse cardiovascular events must be conducted to determine the safety of T replacement. This reflects a growing concern of the FDA, which earlier this year began a study evaluating heart disease, stroke and death in men who were using these products. This was prompted by a 2013 article in JAMA, which suggested T replacement may be responsible for a 30 percent increase in cardiovascular events in men who used the drugs.
The FDA panel also overwhelmingly rejected the application of an oral T replacement called Rextoro, from Clarus Therapeutics. This would seem to be a no-brainer, since of all the ways to take testosterone, a pill is the worst. After it is taken orally, testosterone goes straight to the liver, where it can cause liver damage and cancer.
ACSH s Dr. Gil Ross expains, As the article said, approved therapies are supposed to be safe and effective and giving testosterone orally, or by gel for that matter, has been shown to be neither. Low T syndrome seems to be mainly a diagnosis seeking a treatment, and drug companies are eager to fill the gap with Low-T Treatments, Available Here, Come and Get It! like PT Barnum. Sadly, harried doctors are also complicit, since it s so easy to spend three minutes to give a man whose vigor is flagging, an Rx for Low-T , instead of spending 15 or 25 minutes trying to elucidate the real problem.
ACSH s Dr. Josh Bloom asks, Would someone please explain to me why prescription testosterone replacements are (rightfully) under the microscope while they are sold without any restriction in vitamin stores? It is difficult to walk down the aisle in one of these places without tripping over a carton of DHEA (dehydroepiandrosterone).
He continues, What in god s name is this stuff, which is an androgen (male sex hormone), an anabolic steroid, and is converted to testosterone in the body, doing in vitamin shops? The answer is, as usual, the scummy 1994 Hatch act, which gives it a free pass to be sold as a non-drug supplement because it comes from natural sources. Supplement? No way. If this isn t a drug, then I m Dolly Parton.