Health Care

As testosterone therapy gains popularity, medical controversy increases

Testosterone therapy has become a big business with claims it will build men’s muscles and restore their sex drive. Studies, though, cast doubt.
Testosterone therapy has become a big business with claims it will build men’s muscles and restore their sex drive. Studies, though, cast doubt. Star file photo

For the millions of men who’ve been taking testosterone — and the millions more who’ve probably been thinking about it — there’s some good news and some not-so-good news.

New research this month from the Kansas City VA Medical Center and Harvard Medical School found that this powerful male hormone may not raise risks of heart disease, as some previous studies had suggested.

The bad news: Supplemental testosterone may not deliver on the promise of that extra pep and reinvigorated sex life that led many aging baby boomers to take the stuff in the first place.

Consider these the latest rounds in the expanding medical controversy over the incredible increase in testosterone therapy.

“Testosterone is not a fountain of youth,” advised Rajat Barua, the Kansas City VA researcher who came up with reassuring data that in certain circumstances, taking testosterone is associated with lower heart attack risks.

“It should be treated as a drug just for some people,” he said. “And I hope that they’re appropriately treated.”

Concerns like these prompted the U.S. Food and Drug Administration in March to caution that way too many of the wrong men have been taking testosterone with little evidence that it’s safe for them or that it’s doing them any good.

Indeed, 2.3 million patients received prescriptions in 2013 for testosterone gels, patches, injections and pellets implanted under the skin. That’s up from 1.3 million as recently as 2009. Credit aggressive marketing by testosterone manufacturers, such as the TV commercials featuring a graying, athletic man who applies testosterone gel under his arm before traversing an Indiana Jones-style suspension bridge, hiking a scenic waterfall and strolling on a beach, all the while with his attractive wife by his side.

Meanwhile, doctors offices and clinics specializing in testosterone treatment, including a half-dozen or more in the Kansas City area, have sprouted up across the country with claims they can build men’s muscles, restore their sex drive, improve their mood and help them sleep better.

“Men’s health became sexy,” said Ajay Nangia, a urologist at the University of Kansas Hospital. Nangia said his patients are often bringing up testosterone therapy as something they want to try. “Many times indeed. They say, ‘I’ve got the symptoms, and I want to know if my testosterone is low.’”

Nangia calls the testosterone boom a fad. Others, like Boston University medical school professor Thomas Perls, call it “disease mongering,” a phrase used to describe how drug companies widen the boundaries of diseases to expand the use of their products.

Testosterone advertising “can effectively pit patients against their doctors, pressuring them for compliant prescribing on demand,” Perls recently wrote.

That’s borne out by FDA investigators who recently found that as many as 28 percent of men who’ve been taking testosterone hadn’t even gotten a blood test of their testosterone levels before their doctors issued them prescriptions.

A ‘low T’ boom

The only FDA-approved use of testosterone is in men with devastating conditions, such as testicles damaged by chemotherapy or injury, or hormonal problems that shut down testosterone production by the testicles.

In cases like these, supplemental testosterone has been a proven therapy for decades. It can help boys advance normally through puberty or keep adult men from developing osteoporosis, growing breasts or losing muscle mass or facial and body hair.

But that’s just a fraction of those marching into doctors offices for a testosterone fix. Most are men ages 40 to 64 seeking help for something testosterone manufacturers call “low T,” but that the FDA and much of the medical community often consider normal aging.

The symptoms of “low T” may include fatigue, trouble concentrating, muscle loss and, of course, a lowered sex drive, problems that are common in men as they grow older and their testosterone levels slowly decline. But these symptoms can be caused by a host of other maladies, such as obesity, diabetes and inactivity, that are common among middle-aged men and may affect testosterone levels.

“The one thing we are struggling with now is that age decline of testosterone is not necessarily a reason to treat,” said Nangia of KU Hospital. “There’s got to be symptoms, as well, but a lot of these symptoms also are age-related.”

“Testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging,” the FDA said in its March safety advisory. “The benefits and safety of this use have not been established.”

Those safety issues led the FDA in March to order drug manufacturers to change their labeling to emphasize that testosterone is only approved for men with certain medical conditions. The drugmakers also must add warnings that taking testosterone possibly increases the risk of heart attack and stroke.

The FDA decision came after reviewing seven studies of men who were taking testosterone. The evidence was decidedly mixed. Four of the studies found higher risks of heart attack, stroke or death among these men, while two found no higher risk and one found their risk of death to be lower.

Since then, the evidence may be tipping in the other direction.

Barua and his colleagues at the Kansas City VA looked at data on about 83,000 veterans from throughout the VA system who had low testosterone levels. The researchers found that over several years, the veterans whose testosterone was brought up to normal levels had fewer deaths, heart attacks and strokes than the veterans who hadn’t received testosterone therapy.

“We can say we have confidence appropriately selected patients will benefit,” Barua said. “But inappropriate use remains a concern. It should be discouraged just because a patient says he has low energy or a low sex drive.”

Published about the same time was a study led by Harvard researchers that followed about 300 men with low or low-normal testosterone. Half received testosterone gel. The other half received a placebo gel that didn’t contain any of the hormone.

The researchers followed the men for three years, giving them surveys on how healthy they felt and how their sex lives were going and testing them for hardening of the arteries.

The men who got the real testosterone gel didn’t suffer significantly greater progression of heart disease. But they also didn’t show any meaningful improvement in the quality of their overall health or their sex lives, compared to the men who had gotten placebo gel.

“The major lesson, as I see it, is testosterone should not be used indiscriminately,” said Shalender Bhasin, one of the lead researchers. “Most men would seek testosterone therapy for sexual function and for physical well-being (yet) there’s no condition called ‘low T,’ but we’ve created this artificial epidemic.”

Bhasin said men seeking a boost in the bedroom would be better off asking their doctor for Viagra or similar drugs for erectile dysfunction that have proved their effectiveness.

‘I act like I’m in college’

Bill Reilly isn’t buying any of the negativity about testosterone. The Texas surgeon is not only national medical director for Low T Center, a chain of 45 clinics including ones in Leawood and Independence, he’s also a confirmed testosterone user.

At 67, Reilly said he can bench-press more than 200 pounds and has a better sex life now than when he was in his 40s and 50s. “I act like I’m in college,” he said.

Men seeking testosterone can walk into a Low T Center clinic without an appointment and have their blood test results in 45 minutes or less to see if they meet the clinic’s criteria. About 70 percent end up getting a shot of testosterone, Reilly said.

Typically, the medical professional on site is a nurse practitioner or physician assistant overseen by a local physician. Follow-up testosterone “booster shots” are given at seven- to 10-day intervals. They cost $395 per month for patients who pay themselves.

“The majority of our guys know something is wrong by the time they come to us,” Reilly said. But after they’re in treatment, “some of our guys come back with their wives, who say, ‘Can you help me? I can’t keep up with him.’”

As for the FDA’s concerns over the safety and effectiveness of testosterone for aging men, Reilly disagrees.

“I think a lot of doctors will say no matter how you develop (low T), treat it,” he said. “As you get older, why not?”

To reach Alan Bavley, call 816-234-4858 or send email to abavley@kcstar.com.

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