News & Events

YOUTH FOR SALE

By Kate Tyndall Style Magazine, Baltimore, March/April, 2001, pages 47-51 and 118

Dean and Lauri Kane are taking their patients down the uncharted road of anti-aging medicine. But are they moving too fast?

There is a siren's call issuing from the fifth floor of the Sinai Medical Office Building to the no-longer youthful, promising no less than a walk backward through the doors of aging. But is this song a false and dangerous promise, or an age-old dream come true?

For plastic surgeon Dean Kane and his wife and business partner Lauri, the promise of human growth hormone - what some enthusiasts have dubbed "a face-lift in a needle" - is very real. Now in their second year of an anti-aging practice, the Kanes have developed a six-step program to ameliorate the effects of aging. Some of the solutions they promote are older than their customers: nutrition counseling, food supplements and exercise all make the list, along with such slightly newer ideas as cosmetic surgery and the rejuvenation of skin through the use of Retin-A, skin peels and Botox injections. But the most potent weapon in their arsenal, and the most controversial, is the use of human growth hormone.

They are a petite pair, this duo of dynamic aging. Where Dean is serious and intense, Lauri, with her artfully tousled dark hair and huge eyes, is loquacious and charming. He provides the science, she provides the sell. It's a formidable formula, and when you listen to them talk, you want to believe. At age 55 or 60, who wouldn't want to hear he or she could return their body to the physiologic state it had at 30 - the Kanes' stated goal - and keep it there, no matter the march of time?

Think of the rewards: Lean body mass instead of pockets of pudge. Increased energy and sexual potency. Better skin tone and a reversal of hair loss. All those outer rewards and increased immune protection to boot.

The price? A needle prick once a day for the rest of your life at a cost of $7,000 to $10,000 annually. Given its hefty price tag, using growth hormones could become one of the first new status symbols of the new millennium, since only the wealthy - or those willing to trade debt for youth - can afford it.

But is there a hidden cost in long-term risks, such as faster-growing cancers? Is it, as one well-credentialed endocrinologist argues in light of insufficient long-term study, "today's snake oil"?

Synthetic Human Growth hormone, also known as HGH or its scientific name somatotropin, is no flash in the pan. Five U.S. companies manufacture the drug using a recombinant DNA technique. They include Genentech, which holds the patent, and Pharmacia Corp., which in 1999 sold $461 million worth of its growth hormone, Genotropin.

The U.S. Food and Drug Administration approved the use of human growth hormone in 1985 to treat children who would not attain normal stature without it. More recently, it was approved to treat people who are medically deficient in naturally occurring amounts of the powerful hormone, and to treat the extreme weight loss experienced by people with AIDS.

The FDA has not sanctioned the use of growth hormone as an anti-aging drug, and prescribing it for that purpose, although perfectly legal, is considered an off-label use. Stanley Slater, associate medical director for geriatrics at the National Institute on Aging, says: "At present, there is no proven clinical utility for using growth hormone as an anti-aging drug, though the possibilities for research are very interesting."

Produced by the pituitary gland in the brain, growth hormone is responsible for the growth and health of organs throughout the body. Because young adults deficient in HGH show many of the same bodily changes seen in aging adults, such as increases in fat, decreases in lean muscle tissue and bone density, weaker muscles, more fractures, fatigue and a higher incidence of cardiovascular disease, researchers wondered whether declining levels of growth hormone might be responsible for many age-related problems.

A variety of physicians across a wide range of specialties - sports medicine, plastic surgery and the new anti-aging specialty - feel there is enough evidence out there to warrant the use of growth hormone to reverse some of the effects of aging, and are writing the prescriptions to prove it.

Bust most endocrinologists, the doctors who specialize in studying the glands and hormones of the body, are tempering their excitement over HGH's possibilities, urging long-term studies and just hoping their medical colleagues aren't jumping the gun.

Kane 46, does plenty of peels, lifts and tucks in his practice, but he feels very strongly that hormone replacement and gene therapies (though the latter remain in the development stage) are the future of the anti-aging movement.

While plastic surgery remains a predominantly female province, growth hormone replacement, at least at Dr. Kane's Center for Anti-Aging Medicine and Cosmetic Surgery, is sought more often by men. "It's primarily businessmen in their 50s and 60s who are using growth hormone," Kane affirms from his office on the Sinai Hospital campus. "They come to me because their energy is flagging and they can't do as much as they used to."

"Women endure more," says Lauri Kane wryly. "They are more apt to do something to the outside of their bodies. Men would rather take a pill. They don't want you to see that they've had anything done."

As far as the Kanes are concerned, absent environmental and genetic causes, all remaining diseases are diseases of aging. Kane doesn't expect growth hormone to extend his patients' longevity; the goal is not how long they live, but how well they live and feel. However, it would seem that increased longevity might be a natural outcome of overall good health and well-being.

One of Kane's patients is 54-year old Hal Katz, owner of Katz Insurance Group in Baltimore. "I have lost two inches on my waist without losing body weight, because I have gained muscle mass," he says after six months. "Anybody who knows me notices that right away. My energy level is higher. My attitude is more upbeat. It's hard for me to explain, but when I walk, I feel lighter on my feet."

"The last time I went to my hair stylist, who didn't know I was on this drug, he asked me if I was taking Rogaine or anything, because he said that I had a lot of new hair."

Each shot costs Katz $26. "My wife is a whole lot more skeptical than me," he says, but after she witnessed his results, she jumped on the growth hormone bandwagon, telling him, "I can't allow you to get younger while I get older." She started taking the hormone in October. "She claims that she has an elevated mood," says her husband, and "I notice that her body fat has come down."

How long will Katz take the drug?

"As long as it doesn't interfere with my life and family I will probably continue. But if there comes a time when it causes me harm, I'll come off pretty quick."

Known possible side effects of the hormone include swelling of the feet and hands, arthralgia (pain in the joints), transient increases in blood sugar and blood pressure, and carpal tunnel syndrome, says Dr. Marc Blackman, professor of medicine at Johns Hopkins and chief of the division of endocinology at Bayview Medical Center. Though he says these side effects can often be dealt with by adjusting the dose, it is the unknown, long-term risks that trouble him and his colleagues.

There is no research to show that HGH induces cancer, but Blackman says "a hidden cancer, the proverbial single cell, might have its growth stimulated by the hormone. As a patient advocate, I have to say this is not ready yet."

But if Blackman believes clinical use of HGH is premature, he'd have a hard time convincing Kane's patients of that. Like the Katzes, 55 year-old Carroll Fackler attributes everything from increased stamina to thicker nails and hair to the HGH she has injected for more than nine months. "First I experienced a general sense of wellness," she says. "I noticed I was able to get through my exercise class without being exhausted. And it made my skin look firmer."

"There was also an increase in my good cholesterol, and I've noticed that my nails and my hair are thicker, and I even have less gray in my hair."

Still, like Blackman, other physicians are wary. "The Kanes are good friends of mine," says facial plastic surgeon Ira Papel, "and Dean is a reputable physician. But ask me what do we know about human growth hormone and the answer is, not much." Papel, who has a facial plastic surgery practice in Owings Mills, says. "I don't prescribe it, and I certainly wouldn't use it myself. But like a lot of people, I've looked into it."

"I think it's still very early for the clinical treatment of this hormone. We all know what it is and what it does, but we don't know proper dose levels and we don't know the long-term effect on the human body. This is a human hormone and needs to be treated with respect.

"The Kanes are reputable, solid and friendly," Papel continues. "I don't think they are trying to fool anybody, but they have made an investment in this and believe in it and are going to push it."

"There is no question that growth hormone declines as people age and reaches its low point by age 50 or so," say Blackman. "And there is a strong bit of evidence that the decline is linked to changes in cholesterol and loss of lean body mass, and perhaps quality of life. What is not shown is that long-term treatment is effective in treating this or in attenuating this decline," says Blackman. "In my own mind this is still a research question."

Blackman has been involved in research in the field of aging and hormones for 20 years. He is currently analyzing data from a five-year study of 125 men and women aged 65-88 who had low, but not deficient, levels of growth hormone and sex steroid hormones and received replacement doses of the hormones (either alone or in combination with one another) or a placebo. Each participant was enrolled in the study for six months. Blackman's study was one of a half-dozen similar ones conducted at universities across the country funded by the National Institute on Aging. All the studies have now been completed and analysis should be finished within the year.

Though he is encouraged by preliminary results from the Baltimore study (which showed reductions in body fat, particularly in the men, increases in lean body mass for both men and women and small decreases in total cholesterol in both sexes), Blackman also warns that growth hormone is a powerful stimulus to the growth of breast and prostrate cancers, both of which are diseases more frequently seen in older adults. What Blackman would like to see are controlled studies to assess the risks and benefits of long-term HGH replacement.

"What often happens in these debates is that patients say, "there is enough provocative data out there, and I can't wait," says Blackman. And for those who can't wait, there are the Kanes' center and plenty of other clinics across the country that offer growth hormone replacement among a plethora of anti-aging treatments.

The American Academy of Anti-Aging Medicine, or A4M as it's called by its members, has a list of 22 such clinics on its Web site. Not surprisingly, most are located in the West and Gulf Coast regions of the country, primarily California, Colorado, Texas and Florida. In Hollywood circles, such notables as Nick Nolte, Oliver Stone and Dixie Carter have injected the hormone.

Kane is a member of the A4M, a society founded in 1993 by Dr. Ronald Klatz. Board certified in family practice and in sports medicine, Klatz has written several books on anti-aging and growth hormone replacement, including "Grow Young with HGH."

In 1999, Kane passed his anti-aging boards and was certified by the American Board of Anti-Aging Medicine. However, anti-aging is not recognized as a new specialty by the American Board of Medical Specialties, the body that oversees the training and certification of physicians in the 24 specialties it recognizes. (According to a spokesperson at the ABMS, the American Board of Anti-Aging Medicine has not applied for certification.)

It was a residency in general surgery at Sinai Hospital that brought Dean Kane to Baltimore more than 20 years ago, and the offer of a group practice that lured him back after a two-year fellowship in plastic and reconstructive surgery in Florida. "We thought we'd stay in Florida, but Dean couldn't find a position," Lauri Kane says. "I loved coming back here. For me, it was like coming home." The couple lives in Pikesville with their two children, Erica, 16, and Alex, 14.

Dean, a native of South Miami, met Lauri, a New Jersey girl, in Gainesville back in the '70s, when he was a sophomore and she a freshman at the University of Florida. They married after her graduation, in 1977. Kane was already in medical school at the University of Puerto Rico in San Juan, where he took his doctor of medicine degree in 1980. He opened his own plastic surgery practice here in 1990.

Two and a half years ago, he started educating himself about the field of anti-aging medicine. His experience with elderly patients as director of Northwest Hospital's Wound Care Center, where he has worked since 1994, also fed into his growing interest in human growth hormone and its implications for improving skin health. In February 2000, Kane recast his practice as the Center for anti-Aging Medicine and Cosmetic Surgery.

Dean Kane does not a first glance, or even second, look like the sort of man who would boldly step out in the vanguard of biomedicine. He is not the type of person who sweeps you into his orbit and overwhelms you with the force of his personality. He doesn't joke or use his hands expressively. His smiles often seem strained into a rictus that relaxes only when social pleasantries are dispensed with. What does cause a spark of expressiveness to break through his formality is talking about what he sees as the enormous potential of HGH replacement treatment. Currently, he has a dozen patients taking growth hormone and he, himself, has been taking the drug for more than four months.

"Right now I have patients who are deciding whether to have a face-lift or take growth hormone," he says. "The main risk is in dosing; trying to find the right dose you need to keep your body at the age of 30. Typically, the adult dose is going to be from four- to six-tenths of a milligram a day." Overdosing can cause temporary joint pains and fluid retention, he adds.

Kane considers age 30 the benchmark for replacement levels because "30 is when we have reached our biological peak in optimal hormone levels. This includes the sex steroid hormones like progesterone and testosterone."

Kane orders a battery of blood tests to determine the current levels of HGH and sex hormones, and to measure and assess various indicators of cardiovascular and renal function. Patients also must get a colon and rectal exam, an electro-cardiograph test and a chest X-ray. Male patients must also have a PSA test to check for the presence of prostrate cancer, and women must have a mammogram and a Pap smear. Only if all these tests come back negative can a patient proceed with replacement therapy.

Like insulin, HGH needs to be injected, because the molecule is too large to be absorbed orally. Kane's patients purchase their drug through his supplier, Pharmacia Corp., and inject themselves once a day, in the evening. (The body releases its own HGH in bursts, usually at night during the period of deepest sleep.) Kane keeps track of HGH levels by measuring the hormone it is converted to in the liver - which is called Insulin-like Growth Factor or IGF-1.

This initial round of testing is not cheap. It runs about $1,500, and is repeated at the one-year mark. In addition, Kane rechecks his patients' HGH levels every three months. Cost of the interim tests usually range anywhere from $100 to $600, depending on the number run.

Johns Hopkins' pediatric endocrinologist Michael Levine, who has used the hormone to treat dwarfism in children, says it is difficult to assess normal growth hormone status without doing what is referred to as a provocative blood test: Blood is drawn and the patient is given a chemical agent by IV to stimulate the pituitary's release of HGH. Subsequent blood samples are taken every 15 minutes for up to three hours to measure the actually growth hormone levels. "A static test (measuring IGF-1 levels from a blood sample) is not a good indictor of growth hormone levels," Levine says. "Let me be cynical for a minute. If you wanted to find the largest number of patients with low levels of growth hormone you would do a random test during the day."

The tests aren't the only thing that disturbs Levine. "How foolish is nature?" he asks. "Does it make sense for women over 50 not to have babies? The question is: Is there a real and practical reason for growth hormone levels to decline slightly as we age? I'm open to treating age-related deficiencies, but right now the studies just aren't out there."

And until long-term, controlled risk benefit studies are completed on growth hormone replacement therapy, Levine calls it nothing less than "today's snake oil."

Snake oil or youth in a syringe?

You decide.