To say growth hormone is an interesting drug is to say Pablo Picasso was an interesting painter. There has been much debate about the use of growth hormone as both a performance-enhancing agent - undetectable by standard IOC urine tests - and elixir of youth, along the lines of something Ponce de Leone hoped to find. Athletes swear by it for its ability to build lean muscle and burn fat as much as the aging baby boomers crave its age-defying properties. However, the FDA considers these as unacceptable uses for the hormone in spite of numerous animal and human studies which support it. In fact, they have only approved the drug for the treatment of children who grow slower because of inadequate growth hormone secretion and for children who have undergone kidney transplantation.
Growth hormone is secreted by the pituitary gland. It's a small protein-like hormone, (or peptide), similar to insulin, commonly referred to as human growth hormone or "HGH." HGH is secreted in very brief pulses during the early hours of sleep and remains in the circulation for only a few minutes. It's quickly taken into the liver and converted into somatomedin-C, another small peptide hormone (also known as insulin-like growth factor-one or IGF-I). During adolescence, when growth is most rapid, production of HGH is very high, hence the name "growth hormone."
Children who develop a pituitary deficiency of growth hormone at a young age will never grow normally and are destined to become dwarfs in adulthood if untreated. Human growth hormone therapy was initially developed to treat those children so they could grow to become normal adults. Initially, supplies were very limited, expensive and sometimes contaminated because it was harvested from cadavers, and there was not enough growth hormone available to treat all the children who needed it. With the development of recombinant DNA technology, human growth hormone has become more available and in a very pure, safe, form. The easy availability of growth hormone now provides a new dimension in health care and preventive medicine, at least it would seem. However, regardless of any stated or published benefit HGH has to offer the aging or athletically challenged, the FDA and the health care industry would rather expose you to almost anything else but growth hormone. Why?
After you're done growing, growth hormone must continue to be present (at somewhat lower levels) throughout life to maintain physical and mental health and well-being. Tissue repair, healing, cell replacement, organ integrity, bone strength, brain function, enzyme production, integrity of hair, nails, skin and vital organs all require the ongoing availability of adequate growth hormone. After age 20, growth hormone production falls progressively and consistently at an average rate of about 14% per decade. By age 60, it is not uncommon to measure a growth hormone loss of 75% or more. Physical decline with age correlates directly with decreased secretion of growth hormone by the pituitary gland.
It would stand to reason then that taking growth hormone as we age could stave off the effects of aging. Not totally nor completely, but the benefits from growth hormone replacement reported in the scientific literature and published in numerous peer reviewed journals over the years do include increased muscle mass, improved physical strength, reduced fatigue, decreased fat (especially abdominal fat), increased bone strength, and revitalization of liver, kidney, spleen, and brain functions. Skin regains a more youthful appearance with fewer wrinkles and sexual functioning improves. Cholesterol decreases and cartilage in joints becomes stronger. Osteoporosis, Parkinson's disease and Alzheimer's disease are improved. Healing is speeded. And, a markedly better quality of life has also resulted for AIDS patients receiving growth hormone.
According to an article published in the Journal of the American Medical Association, another important benefit from growth hormone replacement is the purported strengthening of the immune system. A team led by Christian Wiedermann of the University of
Innsbruck Medical School in Austria reported that HGH had stimulated the functioning of polymorphonuclear neutrophils, immune-system cells that fight off bacterial infections. (Age-related declines in the activity of these cells leave older people more vulnerable to infectious diseases.)
With growth hormone therapy, investigators have found that, in most cases, infections decrease, recovery from illness is aided, allergies improve and immune related diseases become less bothersome. The immune system is also an important defense against cancer and it seems logical that cancer might, to some extent, be prevented by growth hormone. Although it has been speculated that growth hormone might speed the growth of cancer, that has not been seen in clinical practice. In fact, improved immunity might logically be expected to reduce the risk of malignancy and speed healing from a treated cancer. Of the many animal experiments using HGH, perhaps the most exciting has been a study by Michael Torosian, M.D., and Robert Donoway, M.D., of the University of Pennsylvania School of Medicine in Philadelphia, in which HGH significantly slowed the spread of lung cancer in rats.
The US National Institute of Aging is confirming earlier medical studies that increased levels of growth hormone, DHEA and testosterone reverse age related changes in bones, muscles, fat, skin & nerves, as reported in the New England Journal of Medicine. This is something high level athletes have known, or at least suspected, for years and you will be hard pressed to find one who will tell you they tried HGH and it didn't work.
Regardless, the FDA won't budge on its stance and you can beg your doctor on your knees all day long and he won't give you a script. Case in point: my father, now 82, just recovered from a bout of pneumonia. He's got arthritis in his knees, he's a little overweight with borderline diabetes and suffers from chronic pulmonary complications as a result of having smoked for 40 years - in my humble estimation, a prime candidate for HGH replacement therapy, and his mind seemed open enough when I suggested he try it. Well, he asked his endocrinologist about it and the guy wouldn't hear of it. The paperwork his office was required to fill out was apparently staggering enough to thwart any further conversation on the matter. Next, the lung specialist-- a nice enough guy-- responded with the expected knee-jerk response to the HGH question: "No, you'll get acromegaly." Now there's the kind of informed answer you want from a doctor. It's as bad as, "Don't run, you'll hurt your knees". Side effects such as carpal tunnel syndrome, acromegaly, and the onset of diabetes reported in medical research were mostly associated with very large doses; certainly nothing near the low doses used in clinical trials in elderly men.
Clearly, these two answers were adamant enough to for me to wonder if we had inadvertently asked them to prescribe rat poison, never mind a drug that shows so much promise, especially for a guy like my dad. Oddly, this is the usual type of answer you'll get from most doctors. Yet, the production of synthetic growth hormone is rampantly on the increase. It seems that production of HGH far exceeds any possible demand for the drug for its FDA approved indication. According to one maker's annual report, there are an estimated 20,000 children currently who are candidates for receiving growth hormone treatment at an average cost of $20,000 per year. This $40 million market is satisfied more than five times over by Genentech's $220 million in HGH sales for, according to their 10K. Eli Lilly & Co., BioTechnology General Corp., Serono of Italy and Denmark's Novo Nordisk A/S are four more companies which produce HGH in this country and abroad. How could they account for even meager annual sales? There just aren't that many dwarfs in the world, yet the companies that produce HGH are flourishing, with annual HGH sales in the hundreds of millions of dollars. This would tend to imply that HGH is somehow being consumed for uses outside of its sole indication. And, believe me, it is.
While it's virtually impossibility to legally take advantage of its benefits, HGH is being produced and sold to a degree that far exceeds its approved use - the treatment of dwarfism and for children who have undergone kidney transplantation. Hence, there seems to be a huge inequity when you look at HGH sales figures, currently in the hundreds of millions of dollars worldwide.
Doctors generally are free to write prescriptions for legal, non-narcotic, drugs for whatever they think it may be effective in treating; not just what the FDA approved it for. If a doctor thinks his patient's treatment should include HGH therapy, he can prescribe it in any way he sees fit. It's the doc's call. The FDA won't bother him even if he prescribed HGH by the truck load. But, doctors don't normally like their minds made up for them and they hate doing paperwork. Particularly when a healthy, well-nourished, well-built adult athlete is feigning something for which the doc should write an open-ended script for 4 IUs of HGH a day. In fact, both Lilly and Genetech have imposed unusual restrictions on the drug so only hormone-deficient children can get it.
Restricting sales sounds good played on the PR machine, but in reality profits for HGH manufacturers are astronomical and drug companies want to sell as much of it as they possibly can. The manufacturing process for HGH is much the same as for insulin. 100 IUs of insulin costs about ten bucks, 13 IUs of Lilly's Humatrope sells for about $300.00. If they're making money on insulin, imagine what they're making on HGH and imagine how they'd like to increase sales. GH promotion by drug companies seems to be attracting attention. Recently, an executive at Genetech and two executives of Caremark, a distributor for Genetech, were acquitted of charges of paying kick-backs to a doctor for prescribing Protropin-- one of Genentech's brands of HGH. Apparently the judge sided with the attorneys for the executives; he agreed the government failed to prove its case. The government usually has sufficient evidence if they seek prosecution, so even if the accused were acquitted, something had to be up or they never would have bothered.
To make the hormone more user friendly, Genetech won FDA approval for a new liquid form of HGH called Nutropin-- no mixing necessary. This is a move clearly aimed at do-it-yourself, at-home, use. Just like insulin. But surely young dwarfs wouldn't be expected to self-inject their HGH. Of course not. HGH is increasingly being sought as treatment for some interesting maladies as the research to support it becomes available. Sever burn and post-surgical treatments are on the rise as well as for the treatment of patients with the AIDS virus, but these increases still don't account for the current sales figures.
Enter the realm of anti-aging. There's no denying the effectiveness of HGH in restoring and regenerating tissues, as well as stimulating fat loss, improving skin elasticity, repairing a withered sex drive, and addressing a host of other decaying youth-oriented characteristics. In a widely reported 1990 study by Daniel Rudman, M.D., and his colleagues at the Medical College of Wisconsin, HGH was found to trim fat, build muscle and improve skin tone in a dozen elderly men. In the wake of Rudman's report, headlines around the country trumpeted HGH as a rejuvenator and age-reverser. Since then, medical journals around the world have bulged with new reports of HGH's many potential benefits, including the possibility that it may help the body fight off infectious diseases and cancer.
But, can growing old and following nature's course of degeneration and eventual illness be considered a degenerative disease worthy of HGH treatment to abate its onset? Not according to any health insurance company, but if you want to foot the bill yourself there are a growing number of doctors who will prescribe it if they can show you have a deficiency of it. Although the drug companies producing HGH have had banner years in sales, a spokesperson for Eli Lilly told me, "any anti-aging program which includes growth hormone replacement does not have Lilly's support nor endorsement, and we do not agree with their use of it, if in fact it is a Lilly product and not a counterfeit one."
The FDA wouldn't talk to me directly about any specific anti-aging clinics that may be involved in HGH replacement therapies, but they did say that any entity prescribing HGH for anti-aging for profit is something the agency would look at seriously.
Well, the FDA has had plenty of time to look and they don't seem too enthused, even when reports surfaced that a certain clinic recently purchased almost $2 million worth of HGH from its distributor.
Now, why couldn't growing small, or weak, or slow, be a suitable condition worthy of HGH treatment? Probably not in our lifetimes, but that isn't stopping athletes from using it. By all accounts, virtually every Olympic caliber athlete is using HGH. And why not? HGH isn't scheduled like steroids and amphetamines are, it's undetectable in a drug test, it's relatively safe - much safer than anabolic steroids, and it really is pretty easy to get unless you try and get it by legal means from your doctor in the US. But that's not the case everywhere.
When I lived in Mexico I buy as many boxes of Humatrope as I want, Lilly's brand of HGH, without a prescription. I dare say, that in many other countries this is also the case, so for athletes who have assessed the risk to reward ratio, getting their HGH is just a matter of smuggling or buying it from a smuggler, if they don't live in a script free zone such as parts of Mexico. It's really no big deal. Unless you are bringing in truck loads, personal use amounts are easy to hide, and really, prescriptions are easy to get. If you want to pay an extra couple of hundred Pesos, there are druggists here who will get you a script to go along with your HGH. I know that's backwards, but that way you are perfectly within your legal right to bring up to three months supply of HGH back to the US with you, according to the US Customs Office. There is even a website that has a map drawn to show you exactly where the pharmacy is in Tijuana with the best price for Humatrope!
Obviously, this is a system in full force and effect for those elderly folks wishing to turn back the clock or athletes wishing to beat it, and don't tell me the drug companies don't know it. Sure, they put on a good face in the US, but that doesn't mean squat, especially to a company that can move $225 million (wholesale) worth of the stuff in just one year. Remember, there are only 20,000 eligible patients for the stuff according to FDA standards, almost a nuisance when compared to the rest of the market.
The bottom line on HGH is this: There's no end to the credible, reliable research which clearly points to the benefits of HGH in both staving off the effects of aging and performance enhancement, yet the medical community remains polarized. There is the camp of doctors and health care professionals who scoff at using HGH for anything other than treating dwarfs, citing ludicrous blanket contraindications such as acromegaly, diabetes, and carpal tunnel syndrome, regardless of treatment or case study guidelines. In my opinion, better expert testimony could be found in a bowling alley. Then there are those who believe the benefits outweigh the risks in certain cases.
As far as performance enhancement goes, the black market seems to be doing a pretty good job of keeping up with demand; bodybuilders use it by the truck load and Olympic powerlifters, cyclists, and sprinters have enough of it on hand for an entire Olympics to be tagged "the Growth Hormone Games." So, I don't think scrubbing the illegalities off HGH for these athletes is going to show much difference in its use. However, there is a huge market for HGH for elderly folks who care about the quality of their lives. HGH may not necessarily make you live longer, but the evidence is there that points clearly to a favorable quality of life. All the research I've read contains virtually the same conclusion: in low doses, the groups treated with HGH showed marked decreases in adipose tissue, increases in lean mass, increases in bone density, enhanced immune system, increases skin thickness, and overall feelings of wellbeing. In fact, another study published in the New England Journal of Medicine pointed out that after six months of HGH therapy in elderly men, 60 - 80 years of age, with a small dose of 0.03mg/KG bodyweight three times a week, showed changes in bone density, lean mass and fat loss equal in magnitude to changes incurred during 10-20 years of aging. That alone should warrant any reasonable doctor to look into prescribing it for appropriate patients. At least enough to read the research so his answer to the contrary could be construed as a little better than comical. One doctor I spoke with was indeed a little bit better read on the subject, pointing out that HGH treatment could increase the risk of prostate cancer. So what? Let's say the patient is 70 years old with a normal PSA count. If he got prostate cancer from his first shot of HGH it would take him 30 years to die from it. Something else will probably get him first.
As with anything else there are pros and cons. However, I'm finding it increasingly suspect that the broad sweep of the medical community is so uneducated about such a potentially helpful treatment. For any doctor to instantly dismiss the thought of HGH therapy, especially in elderly people, without the ability to cite one credible, relatable, study to support his position is at best irresponsible. The research shows that HGH works, and in low doses these studies clearly point to its safety. Thankfully there is a growing number of doctors who understand this bit of wisdom and are beginning to prescribe it with good results. But, that's not to mean their patients will live to be 150, or win a gold medal at the Olympics. What it does mean is that while we are here, why not be here as long as we can with as much youth and vitality as possible? Obviously, this is something the drug companies believe wholeheartedly. If not, they wouldn't be selling so much growth hormone.