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Increasing sales of ‘low-T’ drugs have many doctors worried

Low testosterone is “in large part an invented condition,” and commercials for “low-T” gels, patches and other products are simply playing on older men’s fears about aging.

The push for testosterone treatments continues.

Some TV viewers may find the seemingly endless string of commercials for “low-T” medications annoying.

But for many physicians and other health experts, those ads, which encourage middle-age and older men to “talk to your doctor about whether you have low testosterone,” are troubling as well as irritating.

For as New York Times reporter Elisabeth Rosenthal points out in an article published Wednesday, low testosterone is “in large part an invented condition.”

Indeed, as I’ve noted here before, there is a medical condition characterized by low testosterone — known as hypogonadism or hypotestosteronemia — but it affects a very small number of men. Only about 0.1 percent of men in their 40s would meet the diagnostic criteria for this condition — a number that climbs to just 5.1 percent among men in their 70s.

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The commercials for “low-T” gels, patches and other products are simply playing on older men’s fears about aging. And it’s working. U.S. sales of testosterone gels alone topped $2 billion last year, Rosenthal reports, and that number is expected to double by 2017.

Questionable benefit, risky side effects

It’s a sales trend that has many doctors very worried. Writes Rosenthal:

“The market for testosterone gels evolved because there is an appetite among men and because there is advertising,” said Dr. Joel Finkelstein, an associate professor at Harvard Medical School who is studying male hormone changes with aging. “The problem is that no one has proved that it works and we don’t know the risks.”

Dr. Eric Topol, a cardiologist and chief academic officer at Scripps Health in San Diego, is alarmed by the high percentage of patients he sees who use the roll-on prescription products, achieving testosterone levels that he described as “ridiculously high.”

The gels are of questionable medical benefit for many of the millions of men who now take them, he and other doctors say, and their side effects may well prove dangerous.

“These medicines come with a risk of coronary artery disease,” Dr. Topol said. “When I ask patients why they’re on it, the instant response, is, ‘I have low T.’ I ask, ‘Why would you even get tested for that?’ There isn’t really a normal,” he said. Other side effects include an enlarged prostate, he added.

Research suggests those side effects and risks aren’t minor. A 2009 study, for example, found that men given testosterone replacement therapy were four times more likely to develop cardiovascular problems than those not given the therapy. The findings were so striking that researchers halted the study early — a highly unusual ending to a clinical trial.

Dangerous for kids, too

Testosterone gels also pose health dangers for young children who come into skin-to-skin contact with men who are using the products. A father may, for example, forget to wash his hands or to cover his arms or chest with clothing after applying the gel. If he then touches or picks up his child, he can easily transfer the testosterone to the child.

Such an exposure, especially if repeated, can lead to the development of male sexual characteristics in girls and premature male sexual characteristics in boys.

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Incidents of this happening to children pop up frequently in the medical literature. Earlier this year, two cases were described in a paper in the Journal of Pediatric Endocrinology and Metabolism. One involved a 21-month-old boy who had started to grow pubic hair and whose penis had grown unnaturally large. The other was an almost 4-year-old girl who had also started to grow pubic hair and whose breasts had begun to develop.

Both children frequently slept in the same bed as their parents. And in both cases, the fathers were using a “low-T” testosterone gel, applying it each evening to their arms and chest.

Blood tests showed that the children had elevated levels of testosterone in their bodies. Fortunately, their symptoms abated after the exposure to the hormone was stopped.

“With the increasing popularity of topical steroids for the treatment of low testosterone,” write the authors of the paper, “it is imperative that these therapies be prescribe and used judiciously to prevent harm.”

Rarely cause of erectile dysfunction

As Rosenthal points out, “Studies are just beginning to yield results to address the appropriate use of the [testosterone drugs] in older men.”

So far, those studies’ findings are not going to please the pharmaceutical industry.

“For example, scientists have found that age-related male changes in body fat depend on a different hormone, estradiol, which also decreases with age,” writes Rosenthal. “Likewise, while strength and libido do decrease with falling testosterone levels, that effect may not be significant until testosterone levels are very low.”

Furthermore, she adds, the research is showing that “[l]ow testosterone is rarely the main cause of erectile dysfunction.”

Something to remember the next time a ‘low-T’ drug commercial appears on the TV screen.

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You can read the Rosenthal’s article on the New York Times website.