In Men’s Fight Against Aging, How Much Risk to Take?
The FDA is weighing whether testosterone-replacement therapy is safe
By Melinda Beck
Oct. 27, 2014 4:51 p.m. ET
Aging brings less energy, strength and sex drive for most men. The Food and Drug Administration is trying to decide whether taking hormone supplements, which promise to battle that natural decline, is safe.
More than 2.3 million American men used testosterone gels, patches, pellets and injections last year—twice the number as in 2008. Some experts say these men may be increasing their chances of having a heart attack.
An FDA advisory panel in September urged the agency to require testosterone-product manufacturers to study if there are cardiovascular risks. The panel also recommended new labeling to say testosterone drugs, which were first approved in the 1950s to treat severe hormonal deficiencies, haven’t been shown to be safe and effective for boosting age-related drops in testosterone. Only about half of men filling testosterone prescriptions have been formally diagnosed as deficient in the hormone, according to an FDA review.
It isn’t clear what the FDA will do. But whatever the agency decides, doctors will still be able to prescribe the drugs “off-label.” And for many men, the benefits of boosting testosterone levels, a condition often referred to as low-T, are worth the risk.
Touch of Gray
Lower testosterone comes with age. Here are some symptoms:- Decreased energy
- Reduced sex drive
- Increased fat
- Decreased muscle mass
- Heart attack
- Stroke
- Coronary artery disease
- Blood clots
Testosterone is a male steroid hormone that rises sharply when boys hit puberty. It affects the entire body—voices deepen, shoulders broaden, sperm production begins, and height, strength and sex drive all increase. Levels peak in the early 30s and decline gradually, about 1% a year, as men age.
(Estrogen levels drop off much more sharply in women at menopause. So does the small amount of testosterone women make in their ovaries that affects energy, mood and sex drive.)
Besides lower energy, declines in testosterone also are associated with more fat, depression and memory problems. Such changes occur at different rates in different men. They also can be symptoms of thyroid problems, obesity, alcoholism and other conditions.
“Aging is associated with a lot of other conditions—poor eyesight, poor hearing, bad joints, bad blood vessels, cancer—yet we treat them because it improves quality of life and longevity. Why not low testosterone?” says Abraham Morgentaler, a Harvard Medical School urologist and director of a men’s health clinic in Boston.
‘Men all want to feel younger and more virile, and they somehow have come to believe that low-T medication is the fountain of youth. But we don’t know whether it’s safe. ’
Some doctors apparently aren’t checking patients’ testosterone levels. An FDA analysis of insurance claims found that for 21% of men who filled testosterone prescriptions, there was no record of a lab test, either before or afterward.
Safety concerns have dogged testosterone products for decades. Large doses, which some bodybuilders take to bulk up, have been linked to aggression. Testosterone isn’t recommended for men with a history of prostate cancer, although studies show it doesn’t raise the risk for developing prostate cancer, as was once thought.
The cardiovascular concerns flared this past November when a widely publicized study in the Journal of the American Medical Association of nearly 9,000 veterans being evaluated for coronary artery disease found that those who used testosterone had a 29% higher risk of heart attack and stroke than those who didn’t.
Testosterone prescriptions dropped from about 600,000 a month before the JAMA study was published to about 500,000 a month currently.
The study sparked fierce debate and some criticism from physicians who advocate testosterone therapy. Other studies on cardiovascular risks from testosterone have had mixed results.
A day later, the FDA rejected a petition from a nonprofit, consumer-watchdog organization, Public Citizen Health Research Group, for stronger warnings in the U.S., saying there was insufficient evidence of a risk. Currently, the products’ U.S. labels cite the potential for sleep apnea, congestive heart failure and low sperm counts, and warn that women or children exposed to testosterone could develop male characteristics like chest hair.
Some testosterone-treatment proponents acknowledge the drugs could increase cardiovascular risks because they boost levels of red blood cells, which make blood thicker. But they say donating a pint of blood every few months can keep these levels within normal ranges. “If a patient is carefully monitored, it’s not a concern,” says Mark Rosenbloom, who runs a clinic in Northbrook, Ill., specializing in testosterone- and other hormone-replacement therapy.
The FDA advisory panel, after two days of hearing expert testimony, voted overwhelmingly that more data was needed to assess the heart risks of testosterone products. The panel also recommended that labels should be changed to discourage the drugs’ use for “age-related” declines of the hormone.
Testosterone treatment can cost as much as $300 a month. Some men might have a harder time getting insurance coverage for the drugs if the FDA decides to require changes in product labeling.
Testosterone-product makers, in their own comments to the panel, said the lack of large, controlled studies makes it “difficult to interpret” the long-term impact of the treatment.
For some men, testosterone treatment has changed their lives. Bob Mattioli, managing partner of a medical-device training company in Braintree, Mass., started getting hormone injections about 15 years ago, when he turned 50 and started feeling “dragged out, fatigued and general malaise,” he says.
Now he exercises vigorously, with push-ups, crunches, planks and brisk walks every day. “Is testosterone doing that for me? I don’t know,” he says. “I’m doing that for me, and I think it’s a good combination.”
