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Testosterone therapy is gaining advocates despite risks

Kathy Montgomery
The Arizona Republic
Nov. 12, 2003 11:00 AM

Put yourself in Tom's place.

Still a young man in his mid-40s, Tom got up every day, went to work and came home exhausted, where he spent most nights in front of the TV.

But what really bothered him was that he'd lost interest in sex. And when he had the interest, he couldn't always perform.

Tom's doctor prescribed Viagra. When it didn't work, the doctor offered Tom the phone number of a psychiatrist.

All of that did nothing for Tom's self-esteem. Worse, his marriage started to fall apart.

"It's a big deal when you're married and that goes away," says the West Valley man, who asked that his last name not be used. "It affects your whole relationship."

Then Tom found Alan Miles, an anti-aging specialist in Sun City who discovered something Tom had never imagined. His testosterone level was well below normal.

There's a word for Tom's condition: andropause, also known as Androgen Deficiency in the Aging Male or ADAM. It's been called male menopause and, like the female version, it's treated with hormone-replacement therapy.

The concept is so new that many men have never heard of it, and doctors often fail to recognize the condition. But the development of new testosterone-based drugs and mass-marketing campaigns touting the hormone as a fountain of youth have pushed sales through the roof and ignited controversy in the medical community.

It's a classic case of demand outpacing science. There haven't been studies that conclusively link flagging testosterone levels to the symptoms of andropause, and some experts believe the symptoms have more to do with lifestyle than hormones.

What's more, scientists know little about the consequences of long-term use of testosterone, and answers may be a long time coming.

A slow, steady slide

Unlike menopause, which involves a sudden and precipitous drop in hormones, andropause is a gradual process. Andrew Carroll, a Chandler men's health specialist, says most men reach their peak levels of testosterone between the ages of 20 and 30, and thereafter experience a slow decline.

"Most men who hit 80 have levels of hormones that are prepubescent," he says.

Andropausal men may have little energy and not sleep well. They can lose muscle mass and gain body fat. They may have a higher risk of osteoporosis, Alzheimer's and heart disease. Typically, they lose interest in sex. Often, they become depressed.

Most men chalk up the changes to aging. As with Tom, it's often sexual dysfunction that compels them into their doctors' offices. But not always.

Robert Rubino just felt "kind of crummy."

The 50-year-old Valley Realtor went to see Miles for nutritional counseling but soon progressed to testosterone injections.

"I was going through andropause," he says. "At one point, I actually thought I had breast cancer. Female hormones were kind of kicking in. It was freaking me out. I actually had to have a mammogram and a breast biopsy."

Rubino says he felt better within six months of beginning testosterone replacement therapy (TRT).

"I regained my lean body mass," he says. "That gave me the energy and stamina to go to the gym. I've watched myself transform from a fat middle-aged guy to (where) I feel great."

In the past year, Rubino has lost 85 pounds and reduced his 42-inch waist to a svelte 34 inches.

"People who see the picture on my business card say, 'That looks like your fat, older brother.' "

The testosterone myth

Not everyone is as sanguine about testosterone-replacement therapy.

"It's very popular. It's a hot topic, but I'm not there yet," says David Grossklaus, a Mesa urologist. "I'm not a huge proponent of (TRT).

"There are two types of patients. One is the guy who's been married for a long time and loses his libido. He comes in to talk about that. You check his testosterone level and it's through the floor.

"Type B is the guy who hits 40, 50, who finds he can't do the same things, and wants to try this as a fountain of youth. I call him the weekend warrior. The problem is that they're having a problem facing up to their age."

The myth about testosterone is that it's an effective treatment for erectile dysfunction, Grossklaus says.

"Testosterone has no effect on erectile function. But it does play a role in libido," whether a man is interested in sex.

Grossklaus has other concerns, too. For starters, testosterone is expensive. Injections can cost $150 per month. Gels, creams and implants run even more and are seldom covered by insurance.

Then there are the health risks.

TRT can feed an undetected case of prostate cancer or thicken the blood, increasing the possibility of blood clots and stroke.

Taking testosterone supplements can turn mild forms of sleep apnea into the severe form, tripling the risk of cardiovascular diseases.

It also shuts down the body's natural testosterone production, although that effect is temporary, according to Tucson infertility specialist Peter Burrows.

We don't know

What most worries experts is the lack of research that could definitively address the benefits and risks.

Last year, the National Institutes of Health scrapped an ambitious study of testosterone in men over concerns about the cost of the study and the ethics of exposing participants to the presumed risks.

Kronos Longevity Research Institute in Phoenix is in the early phases of a smaller study that will look at some of the touted benefits, but the results won't be known for years.

"The problem is that no one has looked randomly at adequate numbers of men," says S. Mitchell Harman, director of the institute and the study's lead investigator.

He and other experts note that while a link between some of the presumed risks and benefits associated with testosterone have been shown, only the association has been proven. The results may be due to some other underlying cause.

"In the absence of studies that actually give testosterone to men, you haven't proven causality," he says. "We need to find out if this is going to cause prostate cancer. Right now, we don't know. Meanwhile, millions of men are getting testosterone, and we have no idea what the benefits and risks might be."

Nationally, some men's health experts even question the underlying assumptions of TRT, claiming that andropause is more marketing hype than myth.

But don't tell Tom, who credits TRT with turning around his life.

"The sexual response came first," he says. "I noticed I had more energy."

He began going to the gym, and for the first time in his life, his body responded. Encouraged, he adopted more lifestyle changes, started taking nutritional supplements and changed his diet.

"My fat percentage went from 20 percent to 10 percent in a period of two years," he says.

Most importantly, Tom's relationship with his wife improved.

"We have our normal life back," he says. "It's not like it was when we were 20, but it's a whole lot better than it was."

Testosterone sales

• 1988: Testosterone sales remain steady at $18 million.

• 1993: GlaxoSmithKline starts marketing the Androderm patch. Sales of testosterone products jump to $23 million.

• 2000: Androgel, the gel form of the drug, is introduced. Sales more than double from the previous year to $150 million.

• 2002: Testosterone sales hit $400 million.