TESTOSTERONE MARKETING Frenzy draws wide skepticism

Associated Press

WASHINGTON

“Are you falling asleep after dinner?”

“Do you have a decrease in libido?”

“Have you noticed a recent deterioration in your ability to play sports?”

“It could be Low-T.”

Welcome to the latest big marketing push by U.S. drug companies. In this case, it’s a Web page for Abbott Laboratories’ Androgel, a billion-dollar selling testosterone gel used by millions of American men struggling with the symptoms of growing older that are associated with low testosterone, such as poor sex drive, weight gain and fatigue.

Androgel is one of a growing number of prescription gels, patches and injections aimed at boosting the male hormone that begins to decline after about age 40. Drugmakers and some doctors claim testosterone therapy can reverse some of the signs of aging — even though the safety and effectiveness of such treatments is unclear.

“The problem is that we don’t have any evidence that prescribing testosterone to older men with relatively low testosterone levels does any good,” says Dr. Sergei Romashkan, who oversees clinical trials for the National Institute on Aging, a part of the National Institutes of Health.

Low testosterone is the latest example of a once-natural part of getting old that has become a target for medical treatment. Bladder problems, brittle bones and hot flashes have followed a similar path: from inconvenient facts of life, to ailments that can be treated with drugs. The rise of such therapies is being fueled by demographics and industry marketing.

Baby boomers are living longer and looking for ways to deal with the infirmities of old age: Life expectancy in the U.S. today is 78 years, up from 69 years a half-century ago. And companies have stepped up their marketing to the older crowd.

Doctors say that’s led to an increase in men seeking treatment for low testosterone. Prescriptions for the hormone have increased nearly 90 percent over the last five years, according to IMS Health. Last year, global sales reached $1.9 billion.

“People are living longer and want to be more active,” says Dr. Spyros Mezitis, a hormone specialist at Lenox Hill Hospital in New York.

MASS-MARKET HORMONE

Despite its rising popularity, testosterone therapy is not completely new. Testosterone injections were long used for men with hypogonadism, a disorder defined by low testosterone caused by injury or infection to the reproductive or hormonal organs.

But the latest marketing push by drugmakers is for easy-to-use gels and patches that are aimed at a much broader population of otherwise healthy older men with low testosterone, or androgen deficiency. The condition is associated with a broad range of unpleasant symptoms ranging from insomnia to depression to erectile dysfunction.

Watson Pharmaceuticals now markets its Androderm patch, which slowly releases testosterone into the bloodstream. Abbott has its gel that can be applied to the shoulders and arms. And Eli Lilly’s Axiron is an underarm gel that rolls on like deodorant. Androderm, launched last year, had $87 million in sales, and Axiron, which was launched in 2010, had sales of $48 million last year.

“All of a sudden you’ve got these big players with a lot of money using consumer directed marketing to change the landscape,” said Dr. Natan Bar-Chama, a male-reproductive specialist at Mount Sinai Hospital in New York.

Government researchers worry that medical treatments have gotten ahead of the science.

Male testosterone is mainly produced in the testes and affects muscle mass, sperm production and various sexual characteristics. The hormone can easily be checked with a blood test, but doctors can’t agree on what constitutes a low reading in older men.

Typical testosterone levels for younger men range between 300 and 1,000 nanograms per deciliter, but once levels begin dropping there is little consensus on what makes a “normal number.”

SAFETY CONCERNS

Adding to the confusion over what defines “low testosterone,” there’s not much understanding of whether testosterone replacement therapy actually improves men’s symptoms. Evidence of the benefits of testosterone is mixed, and the potential health risks are serious.

The largest study conducted to date, a 2008 trial involving 230 patients in the Netherlands, found no improvement in muscle strength, cognitive thinking, bone density or overall quality of life among men taking testosterone.

The National Institute on Aging is conducting an 800-man trial to definitively answer whether testosterone therapy improves walking ability, sexual function, energy, memory and blood cell count in men 65 years and older.

Those results aren’t expected until 2014.

In addition to concerns about testosterone’s effectiveness, the long-term side effects of the hormone are not entirely understood because most trials to date have only followed patients for a few months.

The most serious risks include heart problems and prostate cancer.