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 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,” says 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.”
Former marathon runner Damon Lease, 50, had been complaining of low energy
and depression, for which his doctor prescribed a combination of four
psychiatric drugs. But since he started taking twice-a-week testosterone
injections in May, he says he’s been able to stop taking two of the medications
and hopes to eliminate them completely. He says he has more energy, improved
mood and concentration.
“I spent 27 years running long distances, I like biking, I like hiking, and I
guess every guy wants to have an active sex life … I want to keep doing those
things as long as I can,” says Lease, who works as a software company executive.
“I feel 20 years younger.”
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. 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 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.
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,” 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, which by and
large are not pills.”
