by:  Dudley S. Danoff, MD, FACS

The marketing of low serum testosterone (low T) as a common medical condition helped propel sales of testosterone gels, patches, injections, and tablets to about $2 billion in the United States last year, according to IMS Dr. Danoff Tower UrologyHealth, a health-care information company. A recent study published in the Medical Journal of Australia noted that the low-T trend is global. From 2000 to 2011, there was a “major and progressive increase” in testosterone use in 37 countries.

This marketing juggernaut has led us to believe that increased body fat, moodiness as manifested by the “grumpy old man syndrome,” and lack of energy (which can afflict nearly all men, at least once in a while) is indicative or even diagnostic of low T and can be “fixed” by testosterone supplementation.

Medically speaking, the classic endocrine disorder for which testosterone drugs were rigidly developed and federally approved is called hypogonadism. A variety of medical conditions can cause this problem, including undescended or damaged testicles (particularly from mumps orchitis), a tumor in the pituitary gland, or primary testicular failure. These conditions typically result in severe testosterone deficiency associated with poor libido, minimal muscles, and scant body hair. That is the real picture of a hypogonadal patient—not that of the overweight businessman whose erections aren’t as good as they used to be!

Drug companies have tried to convince us that lethargy, in general, is caused by diminished testosterone and that filling a prescription for testosterone replacement will make one feel more energetic.

The reality is that when most men have their serum testosterone checked, it is either normal or perhaps a little low, and they are then prescribed a testosterone replacement medication. Because all preparations of testosterone have a high degree of liver toxicity if taken by mouth, the medications are dispensed as a gel, a topical cream, or a transdermal absorption patch. But it is very difficult to judge a small change in circulating serum testosterone and improvement in mood, energy level, and muscle mass without implicating the placebo effect.

There are certainly justified cases of true hypogonadism, in which testosterone replacement therapy (TRT) is entirely indicated. However, drug makers spent $107 million last year to advertise the top brand-name testosterone drugs in the United States, according to Kantar Media. That amount doesn’t include marketing known as unbranded campaigns, which raises awareness of low T itself. The Food and Drug Administration closely regulates advertisements for brand-name prescription drugs but does not generally regulate unbranded campaigns.

Medical researchers and industry experts contend that the pharmaceutical industry has vastly expanded the market for the testosterone to many men who may not need replacement, thus exposing them to increased health risks such as low sperm counts, congestive heart failure, sleep apnea, acne, and blood disorders. And urologists are concerned about the potential for exacerbating unrecognized prostate cancer. Although testosterone does not cause prostate cancer, should a small focus of prostate cancer be present, exogenous testosterone will certainly act as a “fertilizer,” which may allow the tumor to explode.

No medical specialist can currently predict the long-term risks of testosterone, but experts are all particularly concerned by the dramatic increase of TRT on such a large scale so quickly. Very few patients have true hypogonadism, but many patients certainly have a borderline low T, as defined by marketing quizzes. This diagnosis prompts the patient to seek medical attention and request TRT, which may be entirely inappropriate and downright dangerous.

Testosterone plays a central role in the development of the male sexual organs, as well as muscle and body hair, and has long been a synonym for youthful vigor and vitality. The quest to “stave off aging by manipulating the hormone” is an old business. In 1889, the Lancet reported that French physiologist Charles–Édouard Brown-Séquard began injecting himself with “juice” extracted from crushed dog or guinea-pig testicles. He contended that the injections were rejuvenating powers. Eventually, researchers came to believe that the placebo effect, not the juice, was at work.

In the quest for youth, surgeons began transplanting monkey and goat testes into men in the 1920s and ’30s. That fad ended quickly after one well-known surgeon implanted goat testicles, which apparently emitted a noxious odor, into his patients. This craziness ceased when researchers were finally able to synthesize testosterone, followed by drug manufacturers, who capitalized on this discovery and used it to develop medical treatments for marginal conditions.

It was not until the early 1960s that physicians were able to precisely quantify a man’s testosterone level, by developing sensitive tests to determine testosterone concentration in blood samples. It is well-known that after men reach age 30, their testosterone levels typically decline by 1 percent per year. This fact has not escaped the attention of the pharmaceutical industry, which immediately saw a “condition” ready for treatment.

The takeaway lesson is that if a patient is truly hypogonadal, (marked by significantly low serum testosterone) and manifests the clinical symptoms, which include lethargy, loss of libido, loss of muscle mass, and increased abdominal girth, TRT is truly the answer. For most of us, however, the hype of TRT and its widespread use is not justified.

2018-02-14T20:22:41+00:00