Researchers at Georgetown University collected data from 156 randomized control trials conducted between 1950 and 2016 that compared testosterone replacement therapy (TRT) to a placebo for sexual function, mood or cognitive function and cardiovascular health. The study found that testosterone provided no consistent benefits, and the placebo was just as effective as TRT.
Critics say pharmaceutical companies market products like AndroGel and Fortesta based on theoretical claims to otherwise healthy men hoping to delay the natural aging process. There is little evidence that the medications work, according to the researchers, and studies have yet to prove their safety.
“Testosterone products are marketed for non-specific symptoms associated with normal aging, but testosterone is not a reasonable treatment for aging,” said Adriane Fugh-Berman, a pharmaceutical marketing researcher at Georgetown University Medical Center and co-author of the study. “Testosterone has known risks and no clear benefits, and shouldn’t be used by men with intact testicles.”
In February 2014, the consumer watchdog group Public Citizen petitioned the U.S. Food & Drug Administration (FDA) to include a “black box” warning for cardiovascular risks on the labeling of testosterone supplements.
Dr. Sidney Wolfe, founder of Public Citizen’s Health Research Group, published an article in the British Medical Journal (BMJ) detailing side effects of the products and the large number of men at risk. Wolfe said he blames the FDA’s lack of action on “the dangerously close connection between the FDA and the [drug] industry.”
The safety of testosterone supplementation is still in question, as numerous studies have linked the drugs to heart attacks, blood clots and strokes. In January 2014, research published in PLOS ONE found that men over the age of 65 had rates of heart attack that rose as much as 3-fold in the 90 days after they filled a prescription for TRT. Other studies published in the New England Journal of Medicine (NEJM) and JAMA Internal Medicine have reached similar conclusions.
Source: PLOS ONE