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hey syb-sibs this is over a year old but might be of interest in light=20 of the recent posts re male hormones i don't have any current info on this company janet --------------------------------------------------------------------------- Will men go too far in using testosterone patch? --------------------------------------------------------------------------- Copyright 1996 Nando.net Copyright 1996 Salt Lake Tribune SALT LAKE CITY (Mar 16, 1996 7:45 p.m. EST) -- Ross Brunetti says the zest went out of his life when he hit his late 50s. He became moody and quick-tempered, often yelling at his wife and co-workers. He always felt tired. "I became a robot," the Midvale resident recalls. "My energy level was so low that if I wanted to get up out of the chair, I'd almost have to think about it." As for sex, "I could have been in a room full of Las Vegas showgirls and would have been happy to keep reading my Popular Mechanics." Today, at 63, Brunetti plays golf, skis and bicycles. He's less temperamental. As for those showgirls, "now I would appreciate what God has created." The retired engineer credits two adhesive patches he pastes to his thighs or upper arms every evening. Made by Salt Lake City's TheraTech Inc. under the brand name Androderm, each skin patch contains a small reservoir filled with testosterone, the hormone that gives men their male characteristics. A month's supply costs about $98. A doctor's prescription is required. Testosterone "replacement therapy" isn't new for men like Brunetti who suffer hypogonadism, in which the body produces abnormally low levels of testosterone due to aging, illness, injury or genetic defect. Such men can suffer lack of sex drive, impotence, fatigue, moodiness, depression, frailty from loss of bone and muscle mass, and loss of male characteristics such as a deep voice and body hair. Most experts say testosterone therapy halts those problems in men who are hypogonadal because their testosterone levels drop below 300 nanograms per deciliter of blood. Normal range is 300 to 1,000. The U.S. Food and Drug Administration approved the patch last September for treating hypogonadism. TheraTech's patch is the newest way of administering testosterone and is viewed as a big improvement over older methods. The patch can be applied to the back, abdomen, thighs or upper arms. Testosterone pills are linked to liver damage and cancer. Creams wash off easily and can rub onto a man's lover, causing her to develop male characteristics. Biweekly injections -- which Brunetti tried first -- are painful and don't provide a steady dose. Injections sometimes cause patients to become more aggressive and irritable. Patches avoid the problem by releasing a sustained, daily dose. And another company's patch must be applied to the scrotum, requiring men to shave their scrotum daily. The convenience of TheraTech's patch may make testosterone increasingly popular with millions of healthy men who aren't hypogonadal, but who suffer mild "male menopause" as their testosterone levels diminish with age. When drug company Smith-Kline Beecham started marketing TheraTech's patch around the world, London's Daily Telegraph cited "growing concern that fashion, not clinical need, will drive demand. Men with lackluster jobs or marriages could be tempted to consider hormone replacement as a way of clinging to the illusion of youth." For men who have low testosterone but not true hypogonadism, the benefits of testosterone are unproven, and it isn't known how they balance against the risks, says Marc Blackman, head of endocrinology and metabolism at Johns Hopkins Bayview Medical Center in Baltimore. He says risks include acceleration of prostate enlargement and prostate cancer, and a possible increase in the risk of heart disease, abnormal heart rhythms and stroke due to changes in blood fats, sleep apnea and increased production of red blood cells. "We don't routinely recommend testosterone treatment for healthy old men who have subtle reductions in testosterone," Blackman says. "They shouldn't rush into treatment prematurely until we're certain (from ongoing studies) it's likely to be effective and not hurtful." William Bremner, an endocrinologist at the University of Washington in Seattle, says testosterone therapy clearly benefits men with abnormally low testosterone, but "it's not so clear for apparently normal, aging men." Some critics worry testosterone therapy in men with low -- but not abnormally low -- testosterone levels amounts to making normal aging into a disease that requires treatment. "It's a philosophical question," says Jacob Robbins, a hormone expert at the National Institutes of Health. "If you're growing older, do you just let it happen or do you try to prevent it?" Brunetti, whose testosterone dropped to between 150 and 175 before treatment, rejects the argument men should age gracefully. "If there is a supplement hormone or anything else that can allow you to live your life to the fullest, pick up your grandchild or go for a walk, why should I or anyone else be limited because you're 60 or 70?" he asks. Brunetti isn't worried testosterone might speed prostate enlargement or cancer. Like all men using the patch or other testosterone therapy, he receives annual blood tests and rectal examinations to detect prostate= cancer. TheraTech estimates as many as 5 million American men have hypogonadism, yet only about 5 percent are treated. Half of the 5 million men are over 65, and the rest are younger but are hypogonadal for reasons other than aging, says Dinesh Patel, 45, TheraTech's president, chief executive officer and co-founder. Low testosterone levels result either when the testes malfunction or when the pituitary gland or hypothalamus fails to send signals to make the testes produce testosterone. Such problems can stem from aging; disease, cancer or injury of the pituitary or hypothalamus; birth defects such as Klinefelter's syndrome; chronic illnesses such as diabetes, kidney failure and AIDS; or damage to=7F the testes caused by injury, poor circulation, cancer, toxic chemicals, chemotherapy, alcoholism and infections such as mumps. The Androderm patch restored normal testosterone levels in 92 percent of hypogonadal men who completed clinical trials at the University of Utah, Johns Hopkins University in Maryland and Sweden's Karolinska Institute. About 9 percent stopped using the patch because of skin irritation. Endocrinologist A. Wayne Meikle, who ran the University of Utah study, says he has prescribed the patch to healthy men over 60 if they don't have prostate problems. "Men are living to an older age and tend to be healthier at an older age, so they want to maintain their lifestyle and vigor as long as they possibly can," Meikle says. "I don't see a problem with administering the patch to them if they have no major medical reasons not to." About 10,000 men already use the Androderm patch. Patel expects first-year sales of $20 million to $40 million. Within three to five years, the patch should generate $200 million annually, he says. If all Americans with hypogonadism used the patch, sales would exceed $4 billion annually, Patel says. Natural estrogen production drops abruptly at the menopause in all women. Natural testosterone production declines gradually in many men, but not all of them, says Charles Ebert, TheraTech's senior vice president for research and development. Blackman says two-thirds to three-fourths of unhealthy older men have low testosterone levels. He says one-third to one-half of healthy men over 60 or 70 have reduced testosterone levels, although not necessarily= hypogonadism. Ebert believes testosterone replacement eventually will become common among aging men, just as one-fifth of America's menopausal and postmenopausal women now receive estrogen-replacement therapy. Twenty years ago, "women were just supposed to age," he says. "They were supposed to get a humped back from osteoporosis. That's what culture and the medical community expected. That's now changing in a big way." Experts now believe the increased risk of breast and endometrial cancer in women who take estrogen usually is outweighed by the reduced risk of osteoporosis and heart disease and by relief of mood swings and hot flashes. Ebert asks: "How many times have men gone into physicians saying, 'I'm tired all the time and my sex life has gone down'? And the doctor says, 'Well, that happens to a lot of people and this is just part of getting old.' In fact, it may be due to reduced testosterone and it can be treated." Some critics fear testosterone might be prescribed for male impotence caused by other problems. But a simple test can determine if a man is deficient in testosterone. Such men should discuss the benefits and risks of testosterone therapy with their doctor, Ebert says. Experts say testosterone doesn't cause prostate cancer. But men's "risk of prostate enlargement and even cancer increases with age, and giving androgens (male hormones like testosterone) may further increase that risk," Ebert says. "People who have a family history or a direct history of prostate cancer or enlarged prostate should not use the product," Ebert says. The testosterone patch also must not be used by those rare men with breast cancer. The Food and Drug Administration requires all androgens contain standard warnings. So the testosterone patch's warning label mentions the possibility of liver cancer, jaundice, hepatitis or other liver damage; the risk of heart failure in people with pre-existing heart, kidney or liver disease; and increased production of red blood cells, possibly causing clotting that can trigger strokes or heart attacks. No such effects were seen among the 94 men who completed clinical trials of Androderm, Ebert says. Experts say the pure testosterone in the patch doesn't cause the liver problems associated with methyltestosterone, the form of the hormone used in pills. Men without enough testosterone become like women in terms of a reduced risk of heart-disease risk. Testosterone therapy may raise their risk to that of other men. Blackman says testosterone treatment also seems to provoke or aggravate apnea, a sudden cessation of breathing during sleep. Repeated apnea episodes can result in abnormal heart rhythms that can trigger heart attack, cardiac arrest or stroke, he adds. Treatment with testosterone also can suppress a man's remaining natural testosterone production, leading to reduced sperm production and even sterility. That's not a problem for older men who no longer want to father children, Ebert says. The Androderm patch should not be used by women because a high testosterone dose can harm fetuses, induce male characteristics and, in female mice, cause cervical and uterine cancer. But an increasing number of doctors prescribe tiny amounts of testosterone for menopausal and postmenopausal women to restore their sex drive. Some critics fear giving women testosterone will raise their heart-disease risks to the level experienced by men. Patel says TheraTech is developing estrogen, estrogen-progestin and estrogen-testosterone patches for menopausal women, who make small amounts of testosterone before menopause. TheraTech -- short for therapeutic technologies -- was founded in 1985 and started issuing stock in 1992. It started by developing "skin penetration enhancers" that made it easier for medications to cross the skin from an adhesive patch. The company's first product, marketed in Europe, was a nitroglycerin patch to treat chest pain. TheraTech also is developing a patch with a drug to prevent urinary incontinence; topical creams for herpes and inflammation; a nicotine lozenge to help people quit cigarettes; time-release tablets with heart-disease drugs; and tablets that stick to the gums and slowly dissolve to deliver drugs for diabetes and osteoporosis. TheraTech has yet to make a profit because it is just starting to sell products after years of development. So far, it has accumulated $37 million in losses. Patel expects the company to become profitable next year, and stock analysts have been bullish on the company's future as its stock price has soared. --------------------------------------------------------------------------- [log in to unmask]