Like many middle-age men who complain that their vigor has vanished, Dr. Douglas Hall, an Ocala obstetrician, began taking testosterone five years ago. "I wanted to stay young," he says.
Instead of feeling better, he felt worse. He gained 30 pounds. He ended up in the hospital with angina.
The problem, Hall deduced, was oversimplifying what he needed. He took too much testosterone and paid too little attention to balancing all his hormones. He studied the subject extensively. He shared what he learned in a story in the local newspaper. The day the story published, his obstetrics and gynecology practice got 250 calls in three hours.
"They all started coming to see me," says Hall, 63.
Today he treats 30 men a week.
"I just want to help them age gracefully."
Men's determination to live young no matter their age has tripled sales of prescription testosterone over five years. Fueling their interest are heavily advertised impotence drugs. Two of them, Levitra and Cialis, will have the first-ever Super Bowl commercials on erectile dysfunction this Sunday. All the publicity has made it easier for men to seek help for their most intimate medical problems.
The hormone testosterone gives adolescent boys deeper voices and body hair. In adult males, the hormone feeds libido, builds muscle mass and helps maintain energy levels, explains WebMD.
Levels typically peak when a man is in his 20s and then slowly decline. By 60, about one in five men will have low testosterone; and by 80, almost half do.
The most obvious result is a dwindling sex drive and inability to get an erection. But inadequate testosterone or an imbalance with other hormones is also blamed for higher body fat, muscle weakness, lack of energy, mental confusion and moodiness, experts say.
The condition has been dubbed male menopause, or andropause.
Men who supplement with testosterone injections, skin patches or skin gels say they feel younger.
"Men love testosterone," says Dr. John Morley, an endocrinologist at Saint Louis University School of Medicine. Morley says testosterone is not a cure-all but "a quality of life drug."
Testosterone's popularity as an antiaging tonic is an off-label use: Testosterone supplementation is approved by the Food and Drug Administration only to treat select medical conditions, such as hypogonadism, when a man of any age has low levels.
No one is certain about the long-term effects of taking testosterone when one's own levels decrease.
Prescription sales for testosterone averaged about $18-million every year until 1988. Then the Testoderm patch was introduced by ALZA Corp. A patch is easier than injections, and sales climbed. But patches can irritate the skin. In 2000, Unimed Pharmaceuticals put AndroGel on the market. Rubbed on the shoulders, upper arms or abdomen, the gel slowly releases testosterone into the bloodstream. It is largely credited with doubling testosterone sales to $500-million. A half-dozen more products are in development at pharmaceutical companies.
As testosterone supplementation expands its market, many endocrinologists fear the hype will lead to bad medicine. Physicians say they feel pressured by patients for "a magic pill."
Les Saunders says he was looking not for magic, but rescue. The 74-year-old retiree was diagnosed as borderline diabetic and put on an 1,800-calorie diet. "I felt like I was starving to death. I had no strength."
Dissatisfied with his family practitioner's complacency, Saunders went to Hall, who took him off the diet and put him on a regimen of testosterone cream and a dozen supplements to enhance his body's endocrine system.
"I gained 10 pounds and the strength I'd been lacking for two years," Saunders says. "I've got muscle again." He regularly plays two hours of tennis and works out on weight machines. His sex life is better, too, he says.
Yet in the recurring dilemma of modern medicine, the media and public are moving faster than the science. There will be almost 17-million American men 65 and older by 2010, many clamoring for hormone therapy, but with no large, lengthy trial to confirm its safety and effectiveness.
Cautions on packaging warn that testosterone can cause breast enlargement and liver damage and may increase the risk of prostate enlargement and cancer. Sometimes there are too-frequent erections, fluid retention and sleep apnea. Testosterone increases red blood cells, which is linked to heart attacks and strokes.
"There is conflicting data," says Dr. Steven Petak of the Texas Institute for Reproductive Medicine and Endocrinology in Houston. "The big question is what happens to the risk for prostate cancer."
As estrogen feeds breast cancer in women, testosterone feeds prostate cancer in men.
Some good news came in a small study published in December. In 20 men who had precancerous cells in the prostate and 55 men who had none, a year of testosterone therapy in both groups resulted in no significant changes in PSA levels.
About 30 studies have reported increased bone density, muscle strength, sex drive and lean vs. fat body mass. Researchers see a connection between low testosterone and depression and are studying supplementation as an alternative to antidepressants.
But only one of the studies lasted more than a year.
A proposed six-year trial with 6,000 men was rejected in 2002. Critics say the $110-million price tag and the potential for harm to participants are to blame. That same summer, a megastudy on hormone therapy for women was halted when participants suffered heart attacks and strokes from a drug prescribed for decades as a preventative.
An Institute of Medicine advisory committee recommended additional small trials on testosterone treatment before a large one is considered.
Further confusing the issue are supplements sold over the counter that promise the same antiaging benefits but need not meet FDA standards for pharmaceuticals.
Men are advised to get a testosterone-level test in their 30s as a baseline for what is normal for them. Tests should be repeated at least every five years.
"Some falloff of testicular function is natural. All organs go through those changes. It may be that's what aging is about," says Petak, a member of the American Association of Clinical Endocrinologists.
But do males go through menopause? Though women's estrogen levels drop sharply in their 40s, men have a wide range of testosterone levels and a gradual decline as they age. Fatigue and impotence blamed on testosterone may instead be caused by diabetes, heart disease, thyroid problems, obesity, depression and stress.
Saunders says his family doctor told him there was no reason for testosterone treatment. When Saunders asked what he could do to feel better, he got no answer. That's when Saunders went to Hall.
"I'm healthier than I've been in probably 20 years."
Could it be low testosterone?
Dr. John Morley of St. Louis University School of Medicine offers this questionnaire for men to assess whether they may be testosterone deficient. If you answer yes to question 1 or 7, or at least three of the other questions, you may have low testosterone. Men should first rule out depression as a cause of these symptoms.
1) Do you have a decrease in sex drive?
2) Do you lack energy?
3) Have you experienced a decrease in strength and/or endurance?
4) Have you lost height?
5) Have you noticed a decreased "enjoyment of life?"
6) Are you sad or grumpy?
7) Are your erections less strong?
8) Has there been a deterioration in your ability to play sports?
9) Are you falling asleep after dinner?
10) Has there been a deterioration in your work performance?