An accompanying editorial, dated February 21, 2017 pulls no punches with regard to what testosterone supplements are indicated for through official FDA approvals, and the market that has mushroomed around a largely-manufactured need known as ‘Low-T’ for increased energy and vitality that only testosterone therapy can seemingly provide.
“Hopes for hormonal rejuvenation appear periodically throughout history – with the most prominent attempt occurring around the turn of the 20th century only to vanish in the 1930’s following the discovery of testosterone, which discredited testis extracts and manipulations,” writes David J. Handelsman, MB BS, PhD, CRACP, FAHMS in the editorial that accompanied the study. “In recent decades, there has been a renewed attempt for hormonal rejuvenation with testosterone in men.
“Today, [eight] decades since the first clinical use of testosterone, the sole unequivocal indication for testosterone treatment is as replacement therapy for men with pathological hypogonadism (ie, organic disorders of the reproductive system).” The editorial went on to suggest that in spite of no proven new indications, global testosterone sales increased one hundredfold over the last three decades, including increases of fortyfold in Canada and tenfold in the US from 2000-2011.
The increased sales were achieved, it was suggested, through the undertaking of marketing strategies circumventing the need for efficacy and safety testing of testosterone for male aging by stretching the definition of the term hypogonadism to encompass virtually any condition associated with low circulating testosterone levels.
Promoted as “Low T” (andropause or late-onset hypogonadism), this process was facilitated by “individual physicians and professional societies that minimized the fundamental distinction between pathological hypogonadism and functional states (including aging) associated with low circulating testosterone levels.”
In other words, testosterone is known to diminish with age. That’s normal. However, middle-age men who are more active than their parents and grandparents at that age – and lamenting the loss of energy – have been buying into the ‘Low-T’ pitch with use of testosterone supplements for the promise of increased energy, strength and virility, without realizing the supplements could harm them needlessly.
There has always been a cardiovascular risk associated with testosterone supplementation. However, for the indications originally approved by the US Food and Drug Administration (FDA) – namely a severe depletion of natural testosterone known as hypogonadism – the benefits were always deemed to outweigh the risks. Hypogonadism can, in of itself pose health risks to the patient.
However, in recent years manufacturers of testosterone supplements have been accused of creating a new market for their products through aggressive promotional tactics.
In the study, published February 21 in JAMA, researchers affiliated with the Perelman School of Medicine at the University of Pennsylvania sought to determine the benefits, and risks associated with testosterone therapy. What are the testosterone side effects? What is the risk for testosterone heart attack? The primary question researchers wanted to answer: “Is testosterone treatment of older men with low testosterone associated with a decrease in non-calcified coronary arterial plaque volume?”
The researchers found that in a controlled clinical trial, “one year of testosterone treatment of men aged 65 years or older with a low serum testosterone level was associated with a significant increase in noncalcified coronary artery plaque volume” of 41 mm more than placebo. Half of all participants were given AndroGel, whereas the remainder were administered a placebo.
READ MORE TESTOSTERONE TREATMENT LEGAL NEWS
There are currently about 6,000 testosterone lawsuits housed in multidistrict litigation centralized before US District Judge Matthew Kennelly in the Northern District of Illinois. Plaintiffs allege various testosterone side effects, including testosterone heart attack and testosterone stroke. They assert that manufacturers aggressively promoted testosterone supplements for indications not supported by the FDA without divulging the risk for serious health consequences, including the potential for testosterone death in rare cases.
Bellwether trials alleging AndroGel testosterone side effects are due to begin this summer.