Marketing frenzy for testosterone draws skepticism from some doctors

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 the nation'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," 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 being fueled by both 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: Spending on print and television ads promoting testosterone by firms like Abbott and Eli Lilly has risen more than 170 percent in the last three years to more than $14 million in 2011, according to advertising tracker Kantar Media.

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," 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 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 range of unpleasant symptoms ranging from insomnia to depression to erectile dysfunction.

Drug companies peg this group at about 15 million American men, though federal scientists do not use such estimates.

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

But 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."

Some doctors believe testosterone levels below 300 lead to sexual dysfunction in older men, but the rule does not cover all cases. A 2010 study by researchers at the University of Manchester and other European institutions found that 25 percent of men with testosterone levels above that threshold had the same sexual problems used to diagnose low testosterone. Adding to the ambiguity is that testosterone levels change by the hour, so a man who takes a blood test for testosterone in the morning may get a completely different reading when tested in the afternoon.

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. Muscle mass increased 1.2 percent, but not enough to improve physical mobility.

The National Institute on Aging is currently 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. But 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. But the most serious risks include heart problems and prostate cancer. In fact, all testosterone drugs carry a warning that the hormone should not be given to men who have a personal or family history of prostate cancer.

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 a serious heart event, including congestive heart failure, than those taking placebo. A review of 19 testosterone trials in 2006 found that prostate cancer was significantly higher among men taking testosterone.

Also in 2006, the Endocrine Society published the first physician guidelines for prescribing testosterone for men with androgen deficiency. All six of the co-authors had received consulting fees or research funding from drugmakers that market testosterone. Despite those ties, the authors took a cautious tone, stressing the difficulty of accurately diagnosing low testosterone and acknowledging that they were unable to reach an agreement about when doctors should begin therapy. They also recommend doctors have an "explicit discussion of the uncertainty about the risks and benefits of testosterone therapy."

History has shown that hormone replacement therapy can be dangerous. That hit home for women in 2002 when a landmark study shook up the conventional wisdom about the benefits of estrogen replacement therapy for menopause, the period when women stop producing eggs and the hormone estrogen. The federal study found that women taking hormone pills were more likely to suffer heart attacks, breast cancer and strokes. Doctors now generally recommend hormones only to relieve severe menopause symptoms -- in the lowest possible dose and for the shortest possible time.

In the case of testosterone, Abbott Laboratories says Androgel and other drugs like it are an important treatment option for men with low levels of the hormone. But the company acknowledges that more study is needed.

"Abbott believes that the long-term effects of testosterone replacement therapy should be studied, which is why we continually fund and support additional clinical trials, such as the National Institute of Aging's testosterone trial," the company says.

Doctors who prescribe testosterone say more men should be talking to their doctors about the hormone. "If an older man feels excessively tired or his erectile dysfunction has worsened he should be asking `Is there something wrong with my testosterone?"' says Mezitis of Lenox Hill Hospital. "The awareness should be much broader than it is at this point."

Even critics of the testosterone craze acknowledge that the interest in anti-aging products may be inevitable as life expectancy increases. But they say doctors can do more to help seniors by focusing on lifestyle adjustments that keep them connected to their friends and family, rather than prescribing drugs.

"We really 'medicalize' seniors so much that they think the secret always has to be scientific," said Dr. Nortin Hadler of the University of North Carolina at Chapel Hill, who has written four books on excessive medical care. "We need another perspective to understand the secrets to healthy aging, which by and large are not pills."