Testosterone Frenzy Is All Too Familiar

Bonnie: Have we not learned from the thousands of needless cancers from HRT in women?

Courtesy of AP

"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 claimtestosterone 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 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.

"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.

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 placebos. 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 drug makers 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.

"We really 'medicalize' seniors so much that they think the secret always has to be scientific," says 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."