Is growth hormone the magic elixir that can stop the aging process? Not according to the scientific literature. In fact, when misused for this purpose, clinical data indicate that the risks far outweigh any minimal potential benefits. For this reason, the US Food and Drug Administration (FDA) has approved growth hormone for a narrow indication — for children and adults who are truly deficient in it, as determined by strict diagnostic tests.
Yet "antiaging" clinics and websites that promise renewed vitality from "growth hormone replacement therapy" abound. And every so often, a physician is caught inappropriately prescribing growth hormone — possibly to patients that he or she has not seen or to professional athletes seeking a performance boost — which hits the headlines.
In March of this year, for example, Andrew D. Pauli, MD, a Washington-state psychiatrist and medical director of the Elan Vital Longevity Institute, admitted to unprofessional conduct related to 5 patients whom he treated with human growth hormone (HGH).
Dr. Pauli confessed to not properly diagnosing a deficiency in growth hormone, for which he agreed to pay an $8000 fine, attend a 2-day ethics course, and be put on probation for up to 4 years, during which time he can practice medicine but can't dispense growth hormone.
In some ways Dr. Pauli is typical — most of those inappropriately prescribing growth hormone are not endocrinologists or geriatricians, the specialists who should be prescribing such therapy. But in another way he is not typical — he was apprehended, but most physicians engaging in this decidedly shady practice are not.
Appropriate vs Inappropriate Use
Endocrinologists and other experts contacted by Medscape Medical News to shed light on this technically illegal practice all agreed that growth hormone has clear benefits when given to the right patients, but virtually no benefits and a possibility for harm when it is dispensed inappropriately.
"There is good evidence that adults with growth-hormone deficiency when supplemented with growth hormone feel more energetic and have slightly better lean-body-mass to fat-body-mass ratio," said endocrinologist Ronald Tamler, MD, from Mount Sinai Diabetes Center, New York.
However, "growth-hormone supplementation [in adults with no deficiency] has not been associated with improvements in longevity or any other relevant benefit," he asserted.
And the experts all stress that the decline in levels of growth hormone that accompany normal aging can in no way be considered a "deficiency."
The FDA approval for the use of HGH is limited to a few conditions: as well as children with a growth-hormone deficiency and adults with growth-hormone deficiency due to rare pituitary tumors, there are just 2 other legal indications: HIV/AIDS muscle-wasting disease and short bowel syndrome.
And Section 333e of the Food and Drug Cosmetic Act states that HGH is authorized for these specific medical conditions, "but not for use for antiaging, body building, or athletic enhancement."
But this illicit practice continues to be a problem. Just last December, the FDA issued an alert warning that importing unapproved growth-hormone products and selling them in longevity clinics as a "fountain of youth" that ups body mass, weight loss, libido, and stamina violates this section of the act. Penalties for breaking the law include fines and up to 5 years in jail for treating adults.
The FDA also strictly defines ways to diagnose growth-hormone deficiency, which agree with guidelines from the American Association of Clinical Endocrinologists (Endocr Pract. 2009;15 Suppl 2:1-29) and the Endocrine Society (J Clin Endocrinol Metab. 2006;91:1621-1634; J Clin Endocrinol Metab 2011;96:1587-1609).
Merely determining that an adult has low levels of insulinlike growth factor-1 (IGF-1) is not sufficient — unless the patient has deficiencies in multiple other pituitary hormones or had childhood growth-hormone deficiency. To be diagnosed with HGH deficiency, a patient must also have a subnormal response — a peak HGH level below 5 ng/mL — in a growth-hormone stimulation test.
Some devious doctors might do a stimulation test but use a test that is less sensitive or specific to show that a patient has a deficiency, said endocrinologist Mark E. Molitch,MD, from Northwestern University Feinberg School of Medicine, Chicago, Illinois.
"It's fairly common [for unscrupulous individuals] to come up with a diagnosis of adult growth-hormone deficiency using [tests] that are not appropriate," agreed S. Jay Olshansky, PhD, from the School of Public Health, University of Illinois at Chicago. Dr. Olshansky has a special interest in aging research.
"Brazen, Widespread, Medically Dangerous"
Since growth hormone is legally available, "many unscrupulous prescribers in Canada and the US have taken advantage of [this] to prescribe it off label," said endocrinologist Shereen Ezzat, MD, from the University Health Network and University of Toronto, Ontario.
"Antiaging clinics are all over the place," he continued. "They prescribe...regulated compounds, including hormones and steroids and all sorts of other concoctions that they put together in their own pharmacies."
In fact, this practice is, "brazen, widespread, highly marketed, and medically dangerous," said Thomas T. Perls, MD, a geriatrician from Boston University School of Medicine, Massachusetts
Dr. Perls runs his own dedicated website detailing the perils of inappropriate use of HGH and has also published widely on this topic, including coauthoring commentaries published in the Journal of the American Medical Association (JAMA 2005;294:2086-2090; JAMA 2008;299:2792-2794) and a perspective published in Drug Testing and Analysis (Drug Test Anal 2009;1:419-425).
He says that antiaging clinics — also called wellness, longevity, or life-extension centers — appeal to 3 types of customers: "relatively young men seeking drugs to enhance body building, professional athletes who try to get an edge, and finally middle-aged individuals who are falling for the scam that these drugs stop or reverse aging."
But by far the largest market is the last, that of antiaging, he says. "Just the name 'growth hormone' invokes visions of the fountain of youth. Thus, with deceptive marketing, illegal and dangerous HGH distribution has become pervasive. Many people have been misled into believing in the purported magical powers of HGH."
In 2008, he searched online and found 276 antiaging-type clinics and 26 compounding pharmacies, which he estimated were only 10% of centers that are distributing growth hormone for "antiaging" purposes. Most of these are in "retirement states" such as California, Nevada, Texas, Arizona, and Florida.
And Dr. Perls says little has changed in the past 5 years: "It's still illegal to use growth hormone as an antiaging intervention, [and] it's still being used all over the place."
Review of Clinical Efficacy, Safety
But none of the scientific evidence supports the myriad of claims made by antiaging clinics for the benefits of HGH.
An often-cited 2007 review article by Hau Liu, MD, MBA, MPH, and colleagues (Ann Intern Med.2007;146:104-115) remains a valid summary of the benefits vs risks of giving growth hormone to healthy individuals, say the experts.
After searching for randomized controlled trials published until November 2005, the researchers identified 31 trials describing 18 populations and 220 participants with a mean age of 69, who were treated for up to a year.
Compared with other participants, those treated with growth hormone had an increase in lean body mass and a decrease in fat. But they were also significantly more likely to have soft-tissue swelling, joint pain, carpal-tunnel syndrome, and benign enlargement of breast tissue, and they were somewhat more likely to develop type 2 diabetes.
Thus Dr. Liu and colleagues conclude: "On the basis of this evidence, growth hormone cannot be recommended as an antiaging therapy."
Above-normal levels of growth hormone are "certainly bad for you," said Dr. Molitch, noting that patients with acromegaly, who have an excess of growth hormone, have increased mortality, diabetes, high blood pressure, and heart disease.
Another concern is that growth hormone "may promote the growth of malignancies," said Dr. Tamler.
And ironically, growth hormone can actually accelerate aging, Dr. Olshansky noted.
Unrecognized Specialty, Little Monitoring, Huge Profits
Everyone agrees that it is difficult to know exactly how widespread the inappropriate dispensing of growth hormones — a lucrative, often cash-only business — really is.
"So much of [the prescribing] is done off-label for indications that are not clear," Dr. Molitch said. "It's kind of hard to put your hands around a number."
One of the best estimates of the extent of this practice comes from an AP analysis of IMS Health data reported last year. Endocrinologists believe there are fewer than 45,000 US patients who might legitimately take HGH. They would be expected to use roughly 180,000 prescriptions or refills each year, given that typical patients get 3 months' worth of HGH at a time. Yet US pharmacies supplied almost twice that much HGH — 340,000 orders — in 2011.
Indeed, claims Dr. Perls, profits from the illegal sale of growth hormone can rival that from crack cocaine. And despite a federal clampdown on imports of cheaper supplies of HGH from overseas in the mid-2000s, "The biggest profits come from when you can buy growth hormone from China very cheap and then you turn it around and sell it at huge profits," he says. For example, he examined records from a pharmacy in New York that purchased $2500 of growth hormone from China, which it managed to turn into sales of $1.2 million.
Nevertheless, the domestic market for approved HGH is thriving due to the tightening of restrictions on overseas HGH, according to the same in-depth AP investigation. It found that from 2005 to 2011, inflation-adjusted sales of HGH rose 69% in the United States, whereas sales of typical prescription drugs rose by just 12%. Thus, pharmaceutical companies are benefiting from this, with sales of HGH to the 3 biggest firms marketing it in the United States approximating $1 billion in 2011, according to the AP.
As a result, individuals are paying up to $12,000 a year for growth hormone, said Dr. Perls. Cost is therefore a major factor why many discontinue it after a few months. Others include a lack of tangible benefit and presence of unpleasant side effects, he said.
There is an urgent need for adequate resources to investigate and prosecute offenders, Dr. Perls added. However, he's not certain the political will exists: "In the US, we have some pretty good laws, but the [Drug Enforcement Administration] DEA and the FDA are overwhelmed with more serious violent crimes."
Advising Patients to Avoid Scams
So, in the meantime, medical professionals need to be able to counsel patients about the appropriateness of growth-hormone therapy, says Dr. Ezzat.
"Typically a patient [will] say: 'I want hormone X,' and our job is to say, 'Okay, are you, or are you not, deficient in hormone X?... If you are not, this doesn't apply to you and it doesn't really make sense to use it,' [since it] is not a recognized indication where benefits can outweigh the risks."
Another important issue that unsuspecting consumers often do not realize is that "antiaging" or "age management" is not recognized as a specialty by the American Board of Medical Specialties, Dr. Perls pointed out.
"If people think that they have a problem with their hormones, they should seek out a board-certified endocrinologist," he added. "To me, growth hormone for indications other than those that are medically sound is just pure scam."
"I'm afraid there are no quick fixes to aging," concluded Dr. Olshansky, stressing that a proper diet and regular exercise remain the mainstays of remaining healthy with age.
Dr. Molitch receives research support from Lilly and Novo-Nordisk and has done consulting for Lilly, Novo-Nordisk, Serono, and Genentech, which are all companies that make growth hormone. The other physicians have reported no relevant financial relationships.
Medscape Medical News © 2013 WebMD, LLC
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Cite this: Fountain of Youth? Perils of Growth Hormone for 'Antiaging' - Medscape - Sep 23, 2013.