Fabled for its ability to fire up your body’s energy, bulk and sex drive, testosterone has muscled its way into the marketplace. And though AndroGel, the first testosterone gel approved by the Food and Drug Administration (FDA), is just hitting the shelves, warnings are already being issued that the topical sex hormone could follow Viagra onto the burgeoning black market for pharmaceuticals.
Sold in condiment-style foil packets, AndroGel is the latest prize in the drug industry’s race to capture sales by making therapies easier to use. Unlike already-marketed versions requiring self-injections or patches, AndroGel is a clear, colorless gel that is rubbed on the skin and disappears in minutes. (Compounded—specially prepared—gels and creams can be purchased more cheaply from pharmacies.)

For the estimated 50 percent of men—and some women—with HIV who have low levels of testosterone, this is surely a welcome change: no more self-inflicted pricks, needlepoint blemishes or eyesore patches. (On when and how to safely use testosterone, see “Holy Hormones!” page 107.) But the release of this prescription product also opens the door to “huge potential abuse” by the More! Bigger! Harder! crowd, says David McDowell, MD, medical director of the Substance Treatment and Research Service at Columbia University. Will gay men who don’t need hormone supplements be first in line? “It’s anecdotal, but yes,” McDowell replies. “I think some gay men are more obsessed with the archetypal body image than is the rest of the population.” He notes that over-the-counter hormone-precursor supplements and various anabolic steroids have long been big business among gym bunnies.

McDowell cites an April cover story in The New York Times Magazine, where gay gadfly Andrew Sullivan boasts of his testosterone use: “My collar size went up from 15 to 17-and-a-half in a few months; my chest went from 40 to 44. My appetite in every sense of the word expanded beyond measure.” While the HIV positive Sullivan was taking the product under the close supervision of his doctor, public health observers warn that such “miracle” tales could tempt men without hormonal deficiencies.

Why the worry? Taking testosterone when your body makes enough on its own, thank you, can cause such problems as “’roid rage” (inappropriate aggressiveness and hostility), severe acne, impotence, testicular atrophy and accelerated development of prostate tumors. When doses are substantially higher than needed—a particular risk with injections—there is also a danger of liver damage, male breast development and blood thickening (which may lead to heart problems).

But the manufacturer of AndroGel, Unimed Pharmaceuticals—a small Illinois-based company that also sells Marinol, the marijuana substitute—has few concerns about abuse. “We don’t expect there to be a huge black market like we’ve seen with Viagra,” says Kate Robertson, AndroGel’s product manager. “There is no way to get this without a prescription, and we are not promoting it off-label.”
That is what Pfizer, the company that produces Viagra, said back in 1998. The top-selling impotence drug went from Bob Dole’s nightstand to Miami’s night clubs quicker than you could say, “Sixteen-year-old sub-urban boys are now hosting Viagra-and-Ecstasy Fridays.” Pfizer has taken heat recently for tacitly promoting abuse by sexing up its TV spots with younger men and fun-loving couples. “The company seems more interested in sales than seeing the drug used properly,” says Larry Sasich, a pharmacist at Public Citizen, the Ralph Nader–founded consumer advocacy group. McDowell offers this soundbite: “They made themselves the official Valentine’s Day drug.”

When a drug is launched for an undertreated condition, a pharmaceutical company typically promotes awareness of the condition as much as its brand. Unimed has emphasized that only a small percentage of the estimated four to five million American men with low testosterone levels (hypogonadism) are being treated. In addition to traditional physician outreach, the company is planning direct-to-consumer ads in niche magazines with the taglines, “No patches, no punctures and no pills” and “AndroGel: an easy, effective, invisible gel.”
But, like Viagra, AndroGel’s popularity may rest more with word of mouth and free buzz. With the help of Edelman Worldwide, which handles PR for big pharmaceuticals, the “male menopause” syndrome has already landed on the cover of Time, replete with a nice product shot of AndroGel inside and the headline “Are You Man Enough?”

Just as Viagra brought “erectile dysfunction” out of the closet, AndroGel could make hypogonadism a household word. What happens next will depend on how men answer Time’s question.