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Testosterone Replacement Risky

Wednesday, 02 May 2012 06:48 AM

Eli Lilly & Co. and Abbott Laboratories are offering help to the 13.8 million American men who have low levels of testosterone. Doctors warn demand for the treatments could lead to overuse with deadly side effects.

In what may become one of the most sought after sex enhancement treatments since the introduction of Viagra 14 years ago, new testosterone drugs from Abbott, Lilly, and other drugmakers are in hot demand. Prescriptions for testosterone replacement therapies have more than doubled since 2006 to 5.6 million, according to data compiled by Bloomberg. Sales are expected to triple to $5 billion by 2017, according to Global Industry Analysts Inc.

In clinics and treatment centers sprouting up around the country, men are lining up to get shots, gels, and patches to boost their testosterone. Michael Murray, 43, a home stager in New York and Chicago, is one of them.

“Am I making a deal with the devil? A little bit, but I have to think about my quality of life.” said Murray. “It is like I’m in my 20s again.”

Murray said he doesn’t have any obvious symptoms of low testosterone levels. He simply wants to raise his energy level and give his body building regime a boost. That sort of endorsement may offer promise to the pharmaceutical industry. Still, a growing number of doctors warn that relying on the drug as a fountain of youth risks serious health consequences.

Loss of Libido

Like the millions of women who have opted for hormone replacement therapy, men are choosing to get their hormone levels in line. As many as 13.8 million men older than 45 in the United States have low levels of testosterone, according to a 2006 study in the International Journal of Clinical Practice. The male sex hormone begins to decline after age 30, and tends to drop about one percent each year, though the level of decline varies. Lower than normal levels can lead to a loss of libido, a decrease in bone and muscle mass, and depression, according to the Cleveland Clinic.

Problems may occur when the drug is taken by those who don’t need it, according to health experts. Testosterone can increase the growth of prostate tumors and cause blood clots, infertility, and liver damage, said Edmund Sabanegh, chairman of urology at the Cleveland Clinic. He said he is careful to prescribe the drugs only to patients with a medical need and has seen a rise in patients coming to him seeking a prescription for testosterone who don’t need it.

‘Highly Addictive Drug’

“There are a lot of really bad things that can happen” from misuse of testosterone, said Sabanegh. “I think it is a highly addictive drug and I think we need to be very careful about treating patients appropriately.”

Abbott and Lilly said they don’t condone the use of testosterone treatments by men who don’t have clinically low levels of the hormone. Lilly said its testosterone therapy, Axiron, was approved by U.S. regulators in 2010 based on a study of 155 men who were followed for as long as six months.

Abbott only promotes use of its Androgel for Food and Drug Administration approved uses in men diagnosed with low levels of testosterone by a doctor, said Greg Miley, a company spokesman. Abbott said its marketing is intended to raise awareness about low testosterone.

Both companies said that when used properly, their products provide tremendous help to men with manageable side effects. They said men taking the treatments should be monitored for prostate cancer.

Disease Awareness

“Low testosterone is a chronic, but treatable disease, and our marketing efforts around disease awareness are designed to raise awareness about this,” Miley said.

Abbott spent $20.8 million on testosterone advertising in 2011, according to Nielsen Holdings NV. One television ad opens with a silhouette of a man sitting on the bench as his friends play basketball. The voice-over asks viewers if they have “lost their appetite for romance?” or are “feeling like a shadow of your former self?”

The ads direct viewers to a website called IsItLowT.com. On the website is an image of a troubled-looking man sitting on the edge of a bed, his back toward a woman. Another image shows an overweight man on a scale and there is also a quiz to help determine low testosterone levels.

Lilly began running television, online, and print ads last year for Axiron, which is applied under the arm through a device similar to a deodorant stick. The ads tout the product as “the only underarm testosterone treatment.” The company doesn’t disclose how much it has spent on marketing.

The ads are intended to “help educate men about low testosterone and encourage them to seek treatment,” said Teresa Shewman, a Lilly spokeswoman.

Testosterone Clinics

While growing, sales of the drugs aren’t on par yet with those of erectile dysfunction treatments. The U.S. market for testosterone replacement therapies was $1.6 billion last year, according to data compiled by Bloomberg. Sales of Pfizer Inc.’s Viagra were $1.98 billion and Lilly’s Cialis were $1.88 billion in 2011.

To meet the growing demand for testosterone treatments, clinics are opening across the country. Johnny Mitias, an orthopedic surgeon in Mississippi, decided to open a chain of clinics, called Ageless Men’s Health, after he saw the benefits first-hand by treating his own low testosterone. He now has 15 offices and plans to double the number next year. Mitias said he has 5,000 patients, who each pay $250 a month for testosterone injections.

Strict Guidelines

Blood tests to measure for low testosterone, though, can be unreliable as testosterone levels tend to fluctuate throughout the day, said Peter Snyder, a University of Pennsylvania endocrinologist. He requires men take multiple blood tests in the morning to ensure their levels are below the normal range of 300 to 1,200 nanograms per deciliter.

“It’s likely the dramatic increase in use of testosterone is mostly for people whose blood test is a little bit low, but for no obvious reason other than age,” Snyder said. “It really isn’t clear that those people are going to benefit.”

Snyder, who is studying the effects of testosterone in older men, said the increased popularity signals an overuse of the drugs. He said he won’t prescribe testosterone unless a patient has significantly low testosterone and symptoms, like depression, low sex drive, or fatigue.

Other experts worry that some doctors are misprescribing testosterone as a cure-all for a variety of problems. The Cleveland Clinic’s Sabanegh said he sees men taking testosterone to help with erectile dysfunction or low libido when they are trying to conceive a child. Yet testosterone treatments can make men infertile, a side effect doctors sometimes fail to consider, he said.

Younger Than 60

Mitias said his clinic has strict guidelines on treatment eligibility. Most patients at Ageless Men’s Health are younger than 60 and have testosterone levels below the normal rage recommended by the Endocrine Society, a professional organization for endocrinologists, he said. The clinic also routinely checks for prostate cancer.

Mitias never thought he’d be a guy with low testosterone. He worked out regularly, had a busy surgical practice, and was keeping up with his three kids. That started to change around age 40. He said he began feeling very tired, was having trouble sleeping, and cut back on the gym and playing with his kids.

He went to the doctor and got his testosterone checked. Even though his levels were within the normal range, Mitias says he decided to try taking testosterone because he had many symptoms. He saw an immediate improvement.

“I got an injection on Friday and by Monday it changed my life,” Mitias said. “I told my friend and business partner how great I felt. He got tested and found out he was low, got an injection and it changed his life.”

Copyright Bloomberg News 2012

© HealthDay

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Use of testosterone replacement therapies is skyrocketing, but doctors warn it can come with side effects such as prostate cancer, infertility, liver damage, and blood clots.
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Wednesday, 02 May 2012 06:48 AM
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