One afternoon a few months ago, a 45-year-old sales representative named Mike called "The Dr. Harry Fisch Show," a weekly men's health program on the Howard Stern channel on Sirius XM Radio, where no male medical or sexual issue goes unexplored.
"I feel like a 70-year-old man in a 45-year-old body," Mike, from Vancouver, British Columbia, told Dr. Fisch on the live broadcast. "I want to feel good. I don't want to feel tired all day."
A regular listener, Mike had heard Dr. Fisch, a Park Avenue urologist and fertility specialist, talk about a phenomenon called "low testosterone" or "low T." Dr. Fisch likes to say that a man's testosterone level is "the dipstick" of his health; he regularly appears on programs like "CBS This Morning" to talk about the malaise that may coincide with low testosterone. He is also the medical expert featured on IsItLowT.com, an informational website sponsored by AbbVie, the drug maker behind AndroGel, the best-selling prescription testosterone gel.
Like many men who have seen that site or commercials or online quizzes about "low T," Mike suspected that diminished testosterone was the cause of his lethargy. And he hoped, as the marketing campaigns seem to suggest, that taking a prescription testosterone drug would make him feel more energetic.
"I took your advice and I went and got my testosterone checked," Mike told Dr. Fisch. Mike's own physician, he related, told him that his testosterone "was a little low" and prescribed a testosterone medication.
Mike also said he had diabetes and high blood pressure and was 40 pounds overweight. Dr. Fisch explained that conditions like obesity might be accompanied by decreased testosterone and energy, and he urged Mike to exercise more and to lose weight. But if Mike had trouble overhauling his diet and exercise habits, Dr. Fisch said, taking testosterone might give him the boost he needed to do so.
"If it gives you more energy to exercise," Dr. Fisch said of the testosterone drug, "I'm all for it."
Recommendations like Dr. Fisch's and the marketing of 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 Health, a health care information company. In 2002, sales were reported to be a mere $324 million; around that time, Solvay Pharmaceuticals, which was then marketing AndroGel, began using the term "low T," replacing a previous euphemism for male aging, "andropause." Today the low-T trend is global. From 2000 to 2011, there was "a major and progressive increase" in testosterone use in 37 countries, according to a recent study published in the Medical Journal of Australia.
This marketing juggernaut is running into mounting opposition from some prominent medical researchers and industry experts. They contend that the pharmaceutical industry has vastly expanded the market for testosterone drugs to many men who may not need them and may be exposed to increased health risks by taking them. And drug makers have done so, these critics say, by exploiting loopholes in federal marketing regulations.
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 raise 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. That two-track system, says John Mack, an analyst who runs a blog called Pharma Marketing, has enabled companies to position low T as a malady with such amorphous symptoms — listlessness, increased body fat and moodiness — that it can be seen to afflict nearly all men, at least once in a while. Drug makers also promote low-T screening quizzes directly to consumers, Mr. Mack says, in an effort to prompt men to seek testosterone prescriptions from their doctors.
"You might not have the medical condition as described in the textbook," Mr. Mack explains. "But you may have low T as defined by marketing quizzes, and you go to the doctor and ask for treatment."
David Freundel, a spokesman for AbbVie, declined requests to interview company executives. In a statement, Mr. Freundel wrote: "AndroGel is approved by the F.D.A. to treat adult men with low or no testosterone (hypogonadism) who have been diagnosed by a physician, and has more than 10 years of clinical, safety, published and post-marketing data." He added that the company continues to finance research into the long-term effects of testosterone therapy and that its unbranded informational efforts, like the IsItLowT.com site, "follow F.D.A.'s guidance."
Nevertheless, some public health experts warn that the popularization of testosterone drugs is outpacing research into efficacy and possible harms. The drugs' labels warn users about the potential for sleep apnea, congestive heart failure and low sperm counts; the topical gels warn that women and children exposed to the substances could develop male characteristics like chest hair. Others have raised concerns about the potential for prostate cancer and heart attacks.
"The big thing is, we just don't know the long-term risk of testosterone therapy at this time," says Jacques G. Baillargeon, an epidemiologist at the University of Texas Medical Branch at Galveston who has studied testosterone-prescribing trends in the United States. "It's particularly concerning when you see the dramatic increase happening at such a large scale so quickly."
Seeking a Fountain of Youth
In a TV commercial promoting awareness of "low T," the shadow of a middle-age man sits on a bench watching his friends play basketball in an indoor gym.
"Feeling like a shadow of your former self? Don't have the hops for hoops with your buddies?" says the voice-over for the spot, paid for by AbbVie and currently posted on the IsItLowT site. "You might have a treatable condition called low testosterone or low T."
A few seconds later, presumably after the man is treated with testosterone, the shadow evaporates and a man materializes in the flesh, besuited and smiling. Cue the voice-over: "Step out of the shadows."
Testosterone, which plays a central role in the development of the male sexual organs, as well as muscle and body hair, has long been a synonym for youthful vigor and virility. And the quest to stave off aging by manipulating the hormone is an old business.
Toward the end of the 19th century, Charles-Édouard Brown-Séquard, a French physiologist, began injecting himself with "juice" extracted from crushed dog or guinea-pig testicles, as reported in The Lancet in 1889. Although he contended that the injections were rejuvenating, subsequent researchers came to believe that the placebo effect was at work.
In the 1920s and '30s, surgeons began transplanting monkey and goat testes into men, says Dr. John E. Morley, the director of endocrinology and geriatrics at the Saint Louis University School of Medicine. But that fad ended quickly after one well-known surgeon implanted goat testicles into his patients, where they apparently emitted a noxious odor.
"This is the hilarious history of testosterone," recounts Dr. Morley, who in the past received speaking fees or consulting fees from drug makers that marketed testosterone treatments or planned to do so. "It may not have gotten any better. But, gee whiz, it was crazy."
Researchers were eventually able to synthesize testosterone, and drug makers capitalized on the discovery by using it to develop medical treatments.
The classic endocrine disorder for which testosterone drugs were originally developed and federally approved is called hypogonadism. That condition can be caused by problems like undescended testicles or a tumor in the pituitary gland, typically resulting in severe testosterone deficiency, along with poor libido, minimal muscles and scant body hair. "That is the real hypogonadal patient," says Dr. Richard Quinton, an endocrinologist at Newcastle University in Britain, "not the overweight businessman whose erections aren't as good as they used to be."
In fact, physicians weren't precisely quantifying men's testosterone levels until the 1960s, after the development of sensitive tests to determine the concentration of different hormones in blood samples. These enabled researchers to record men's testosterone levels over time. Dr. Morley and others have reported that, after age 30, men's testosterone levels typically decline by 1 percent a year. To the pharmaceutical industry, that decline was ripe for treatment.
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