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Testosterone boosters sell to millions

Some researchers question promises of drug therapy to aging patients

- Associated Press - Monday, September 10, 2012

"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. Drug manufacturers and some doctors claim testosterone therapy can reverse some of the signs of aging -- even though the safety and effectiveness of such treatments are 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," said Dr. Sergei Romashkan, who oversees clinical trials for the National Institute on Aging, a part of the National Institutes of Health conglomerate of research centers.

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 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. is 78 years, up from 69 years a half-century ago. Companies have stepped up their marketing to the older crowd: Spending on print and television ads promoting testosterone by firms such as Abbott and Eli Lilly & Co. has risen more than 170 percent in the past three years to more than $14 million in 2011, according to advertising tracker Kantar Media.

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

"People are living longer and want to be more active," said Dr. Spyros Mezitis, a hormone specialist at Lenox Hill Hospital in New York. "They no longer consider that because they're older they shouldn't have sexual intercourse."

Despite its rising popularity, testosterone therapy is not 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 drug manufacturers 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 such as insomnia, depression and erectile dysfunction. Drug companies peg this group at about 15 million American men, though federal scientists do not use such estimates.

Watson Pharmaceuticals Inc. 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. 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. "They see the potential, they see the market growth annually, and it's very impressive."

Government researchers worry that medical treatments are getting 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 be checked easily with a blood test, but doctors can't agree on what constitutes a low reading in older men.

In addition to concerns about testosterone's effectiveness, the long-term side effects of the hormone are not entirely understood. In 2010, researchers at Boston University's school of medicine halted a large study of testosterone in senior men because patients taking the hormone were five times more likely to suffer serious heart events, including congestive heart failure, than those taking placebos.

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