They seem to be everywhere – drug ads warning aging men about low testosterone, with “symptom quizzes” asking: Are you sad or grumpy? Is your work suffering? Has your strength or sex drive waned?
It’s a powerful marketing campaign that is driving men to doctors in droves for testosterone-replacement therapy. A study this month in the journal JAMA Internal Medicine said the percentages of men 40 and older being treated for “Low T” more than tripled from 2001 to 2011.
A study this spring in Nature Review Endocrinology said prescription sales of testosterone nationally reached $1.6 billion in 2011, up from about $18 million in 1988.
But despite the treatment’s skyrocketing popularity, medical professionals are deeply divided about it.
Branden Bledsoe, a nurse practitioner at Body Shapes Medical in Louisville, Ky., said replacing the male hormone can boost energy, libido and strength for some middle-aged men. “Why would you want to feel bad for 40 years?”
But Dr. Adriane Fugh-Berman, director of PharmedOut, a Georgetown University Medical Center project advancing evidence-based prescribing, said the treatment “offers no proven benefits for healthy men. Low T syndrome is invented by pharmaceutical companies to sell treatment products.”
Doctors disagree about who should be treated and what is an acceptable level of testosterone for treatment. Experts say normal levels for men range from 300 to 1,200 nanograms per deciliter, with testosterone peaking during the teens and 20s and declining about 1 percent a year after 30.
Skeptics point to possible side effects, such as acne, enlarged breasts, prostate problems, testicle shrinkage and limited sperm production, and some evidence of increased cardiovascular risk in elderly men.
The stakes are high, said Dr. Stephen “Kyle” Dreisbach, a family practice physician with Norton Healthcare who treats some men for Low T. “Once you start on it, you are going to suppress your own production of testosterone. It’s a lifetime commitment.”
Research shows an estimated 3 percent to 7 percent of men 30 to 69 have a testosterone deficiency called male hypogonadism, which they can be born with or develop after an injury or infection.
Symptoms include erectile dysfunction, infertility, fatigue, decreased sex drive, body hair and muscle mass.
Doctors on all sides agree that a man with a clear case of hypogonadism may benefit from testosterone therapy, which can be administered through a gel, a skin or mouth patch, injections, or pellets implanted in soft tissues.
But some medical professionals contend that men who don’t fit the classic definition of hypogonadism also can benefit.
Hal Bomar, 59, a married father and nursing home owner in Louisville, said he’s been getting injections and using testosterone cream since October 2012. He said he’s been athletic for all of his life, exercising and playing basketball frequently, but a couple of years ago began “feeling my age” during workouts.
Bomar sought help at Body Shapes Medical. He said the therapy has boosted his energy and improved his strength and endurance in workouts, allowing him to gain 15 pounds of muscle.
Some research supports this, saying the therapy improves bone density, muscle mass and body composition.
“It’s something that gives you a boost or a lift” – in concert with exercise, Bomar said. “You don’t get better sitting on a couch.”
He said his testosterone levels were in the 400s when he was first tested, and now range from 1,100 to 1,300. He said he gets blood work every 30 to 45 days, and doesn’t worry about problems or side effects, figuring they would be detected by the frequent monitoring.
Bomar fits the profile of many patients at Body Shapes. Bledsoe said most are 40 or older and don’t necessarily have testosterone levels below normal. Although he wouldn’t give testosterone to a man at the “upper limits of normal,” Bledsoe said he puts a lot of weight on what symptoms are present.
“Their libido may be way down. They’re depressed. We’re trying to improve their quality of life,” he said. “Our goal is to get you youthful levels, not push your level super-super high.”
Bledsoe pointed to an interview on the Harvard Medical School Prostate Knowledge website by Dr. Abraham Morgentaler, a Harvard surgeon and urologist.
Morgentaler said research shows side effects such as acne, sleep apnea and breast enlargement are “quite uncommon”; that prostate biopsy studies showed no difference in cancer rates between normal men and those undergoing testosterone therapy; and that he’s found no evidence in the literature of strokes related to the therapy, despite some doctors’ concerns that increased red blood cell production could lead to stroke.
Bledsoe said high testosterone levels actually “promote cardiovascular function,” and Low T is linked to several problems.
And research in the Journal of Sexual Medicine cited an association between Low T and reduced longevity, risk of fatal cardiovascular problems, obesity, depression and other disorders.
The study concluded that men with sexual dysfunction, abdominal obesity and metabolic diseases should be screened for Low T and treated if they have it – although the benefits and risks should be carefully assessed in older men.
Risks and concerns
But Fugh-Berman said that, except for people with true hypogonadism, testosterone therapy is not a proven treatment, and “if you don’t need a drug, the risks always outweigh the benefits.”
The American Urological Association says the therapy should not be prescribed to men with erectile dysfunction who have normal testosterone levels and included it on a list of five things physicians and patients should question.
Testosterone levels, Fugh-Berman said, are “highly variable” by individual; what may produce symptoms in one man but not another, and levels fluctuate throughout the day. She said research has linked playing sports – and even watching a team win on television – to temporarily higher testosterone levels.
She reiterated her contention that money is at the root of the explosion in testosterone therapy, adding that the U.S. is one of only two countries that allow direct-to-consumer drug advertising.
“You can’t turn on the radio without hearing one of these ads,” Dreisbach said.
The Nature Review Endocrinology study said men younger than 50 with classic hypogonadism can benefit from testosterone replacement, but benefits and risks in men older than 65 haven’t been studied sufficiently, and “a general policy of testosterone replacement in all older men with age-related decline in testosterone levels is not justified.”
Other research has reached similar conclusions.
A 2010 study in the New England Journal of Medicine, for example, found higher rates of cardiac, respiratory and skin problems among men older than 65 using testosterone gel compare with those taking a placebo.
Other research found that testosterone therapy may stimulate noncancerous prostate growth and possibly worsen existing prostate cancer.
Experts also warn that testosterone gel can harm women and children who touch it, causing, for example, growth of hair in new places.
Greg Miley, a spokesman for AbbVie Inc., makers of a top-selling testosterone replacement product called AndroGel, would not discuss side effects or benefits of the product, saying only, “We encourage discussion between the doctor and the patient.”
Some Louisville doctors said they take a conservative approach.
Dr. Murali Ankem, chairman of the Department of Urology at the University of Louisville, said he’ll consider the therapy if testing shows testosterone levels below 300 and the patient has more than one clear symptom, such as low libido, erectile dysfunction and decreased muscle mass. He also considers other conditions and the possible effects of treatment. “Not all people who have low testosterone are candidates.”
Dreisbach said he is careful to prescribe treatment only to those who truly need it, and monitors his patients for side effects. He urged people to consult with their primary care doctors.
“There are a whole lot of people I see who don’t need treatment,” he said. “It’s starting to be the ‘in vogue’ thing. ... (But) it’s not right for everyone.”
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