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- Apr 15, 2009
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kids get it in my hood
GH is prescribed to children under certain guidelines.
GH is prescribed to children under certain guidelines.
They prescribe gh for anti-aging purposes not for bbing purposes.
You ain't going to get GH prescribe unless u have a legit medical reason and and you get sent for testing that shows your GH is low such as HGH Provocation test, Insulin Tolerance, or Arginine test. You will have to demonstrate you have an issue producing GH at least two consecutive times before it will be prescribed and covered by insurance.
You have to have a legit reason for getting any of these, too.
2iu a day is standard antiaging dosages prescribed. 6iu a day is in no way a antiaging dosage.
Growth Hormone Deemed Illegal for Off-Label Antiaging Use
News Author: Laurie Barclay, MD
CME Author: Désirée Lie, MD, MSEd
Authors and Disclosures
Oct. 28, 2005 — Growth hormone (GH) is illegal for off-label antiaging use, according to an article in the Oct. 26 issue of JAMA. This article reviews the literature concerning the uses and adverse effects of GH as well as the legal ramifications of selling, using, or prescribing it.
"Prescribing and administering GH has become a routine intervention in an industry that is variably called anti-aging, regenerative, longevity or age management medicine," lead author Thomas Perls, MD, MPH, from Boston University School of Medicine in Massachusetts, said in a news release. "Hundreds of thousands of patients who have received GH in recent years as a purported treatment for aging are unaware that they are receiving the drug illegally."
Authors of the review conclude that 1988 and 1990 amendments to the Food, Drug, and Cosmetic Act (FDCA) make off-label distribution or provision of GH to treat aging or age-related diseases illegal in the U.S. Unlike most drugs approved by the U.S. Food and Drug Administration (FDA), GH can only be distributed for indications specifically authorized by the Secretary of Health and Human Services, and these do not include aging and related disorders. In addition, the FDA has clearly indicated that GH is not a dietary supplement.
The FDA has approved GH only for GH deficiency-related syndromes causing short stature in children, adult GH deficiency caused by rare pituitary tumors and their treatment, and muscle-wasting disease associated with HIV and AIDS. Most GH prescriptions should therefore be for children, but 74% of human GH (HGH) prescriptions in 2004 were for adults aged 20 years and older, and 44% were for adults aged 40 to 59 years, suggesting to the authors that a large proportion of GH sales are for illegal uses.
"Off-label use for many drugs is a normal and accepted practice in medicine, but that is not true for growth hormone," says coauthor S. Jay Olshansky, PhD, from the University of Illinois at Chicago School of Public Health. "According to laws instituted by Congress more than 10 years ago, HGH can only be distributed for indications specifically authorized by the Secretary of Health and Human Services, and aging and its related disorders are not among them. The use of HGH as an alleged antiaging intervention is a major public health concern not just because it is illegal, but also because its provision for antiaging is not supported by science and it is potentially harmful."
U.S. officials have reportedly estimated that in 2004, 25,000 to 30,000 older adults received HGH for antiaging. Many Internet sites and antiaging clinics market HGH, claiming that it prevents or reverses aging and improves nail and hair growth, sleep, skin tone, digestion, strength, weight loss, vision, and sexual function. Claims that aging is caused by an age-related decline in HGH levels and that supplementation can therefore stop or reverse aging have not been substantiated by research to date in transgenic mice or other animal models.
"Although there is no evidence that HGH administration stops or reverses aging, many people spend a great deal of money on these products," Dr. Perls says. "On the contrary, responsibly conducted and peer-reviewed science indicates that HGH could in fact accelerate aging and shorten lifespan. It is associated with very high rates of serious adverse effects, and long-term use could increase one's risk of cancer."
Although GH has been documented to improve some measures of body composition, including increased muscle mass, decreased total body fat, improved skin elasticity, and reduced rate of bone demineralization, these positive effects may be modest and short-lived. Benefits have not been demonstrated on strength, functional capacity, or metabolism.
Significant adverse effects reported with GH include carpal tunnel syndrome, glucose intolerance, diabetes, arthralgia, myalgia, peripheral edema, and elevated triglyceride levels. Long-term GH treatment has raised concerns of an increased cancer risk and the potentiating effects of insulin-like growth factors on cancer.
When sold through Web sites, GH may be expensive, and in some cases distributed without physician supervision. Formulations may include tablets, sprays, or injectables, ranging in cost from $200 to $1,000 monthly. The Federal Trade Commission estimated that one Internet site generated more than $70 million in sales of pills and sprays purported to contain GH or to stimulate its production. In 2004, U.S. sales of GH totaled $622 million for nearly 213,000 prescriptions, not including Web site sales. Worldwide annual sales of GH are estimated at $1.5 to $2 billion.
"Millions of dollars in profits are made off of useless pills and sprays like these," Dr. Perls says. "Pills with GH are destroyed in the stomach, and because the molecule is too large to enter the blood stream via sublingual and nasal sprays, such products have absolutely no biological effect. You might as well be paying hundreds of dollars for sand and water."
Physicians within the antiaging industry estimated that in 2002, 100,000 individuals obtained GH without a prescription. Although GH, unlike anabolic steroids, is not a schedule III drug, Congress specifically authorized the Drug Enforcement Agency to investigate offenses related to HGH distribution. The penalties for distribution or provision of GH for antiaging purposes may include up to five years in prison, or 10 years if the offense involves a minor, with fines of up to $250,000 for an individual or $500,000 for an organization, or alternatively, twice the gross gain or loss from the offense, in addition to forfeiture of property used in or derived from violations of the HGH law.
"In 1988 and again in 1990, the [Food, Drug and Cosmetic Act] enacted very stringent controls with substantial penalties involving the distribution of HGH," says coauthor Neal Reisman, MD, JD, from Baylor College of Medicine and St. Luke's Episcopal Hospital in Houston, Texas. "Hopefully our paper will raise awareness of the legal issues surrounding the improper distribution, marketing, and provision of GH and discourage this criminal practice."
Distributing GH via the Internet is in violation of another law because the FDCA requires that GH must be prescribed by a physician who, "'based upon an individualized determination of a proper course of treatment, authorizes the drug's distribution to a patient under his supervision.'" Numerous Web sites reviewed by the authors showed either no evidence of such supervision, or purported supervision in which the supervising physician never met the patient. Distributors may also be in violation of laws against false advertising or deceptive promotion.
"Given the clinical concerns and the legal issues involved, we believe that physicians or other persons who currently market, distribute, or administer GH to their patients for any reason other than the well-defined approved (ie, legal) uses of the drug, should not do so," the authors conclude. "Pharmaceutical companies that manufacture GH should play a more effective role in making physicians and the public aware of the circumstances in which the marketing and distribution of GH are legal and illegal. Federal and state agencies should be allocated resources to better deal with the illegal distribution of GH. Finally, the FDA and professional and lay organizations are in excellent positions to conduct awareness campaigns to educate physicians and the public about the legal and medical ramifications of GH use for antiaging."
The authors have disclosed various financial arrangements with The American Federation of Aging Research, the Alliance for Aging Research, and/or the National Institute on Aging and Boston University School of Medicine's Evans Medical Foundation in Massachusetts. Drs. Perls and Olshansky have disclosed that they are defendants in a lawsuit brought against them by the American Academy of Anti-Aging Medicine and others.
JAMA. 2005;294:2086-2090
Study Highlights
* Retail and mail pharmacy supplies of HGH in 2004 generated total sales of US$622 million.
* 74% of HGH prescriptions were for adults aged 20 years and older, and 43.7% for those aged 40 to 59 years.
* In 2002, physicians in the antiaging industry estimated that 100,000 individuals obtained the drug without a prescription.
* Another, less common, use of HGH is for athletic enhancement.
* Off-label distribution or marketing of GH to treat antiaging or aging-related conditions is illegal in the U.S.
* Although HGH is not a schedule III drug, the Drug Enforcement Agency has been charged with the authority to enforce laws governing the use of HGH.
* GH is not a dietary supplement. It was approved in 1940 as a drug by the FDA prior to the enactment of the 1994 Dietary Supplements Health and Education Act and cannot be classified as a dietary supplement.
* In addition, HGH is bioavailable only in an injectable form, and this is another reason it cannot be classified as a dietary supplement.
* The prevalence of adult GH deficiency in the U.S. is estimated to be 50,000, and the incidence is approximately 6,000 per year, but a substantial proportion of adults with this condition are not being treated with HGH.
* GH has been documented to improve some measures of body composition, such as increased muscle mass and reduced body fat, but the effects are transient and modest and in one study disappeared after 24 months.
* Adverse effects of GH include arthralgia, myalgia, edema, carpal tunnel syndrome, glucose intolerance, and hypertriglyceridemia.
* A higher risk of cancer is a concern due to the potentiating effects of insulin-like growth factors.
* Adverse effects are seen at doses used for legal indications in patients with AIDS wasting syndrome.
* No studies have assessed the long-term efficacy or safety of HGH.
* The FDCA permits the distribution of HGH in connection with (1) "'treatment of a disease'" or (2) "'treatment of other recognized condition'" that has been authorized by the Secretary of Health and Human Services.
* The FDCA requires that GH be prescribed by a physician who "'based upon an individualized determination of a proper course of treatment, authorizes the drug's distribution to a patient under his supervision.'" Therefore, prescribing without having a patient seen or supervised by a physician is illegal.
* The Federal Trade Commission has indicated that fines and disciplinary action can be brought against distributors who disseminate false marketing information and promote and sell HGH with false claims that cannot be substantiated.
* Provision of GH is legal for children with short stature (defined as a height greater than 2 SDs below the mean for age and sex) who have GH deficiency, poor growth due to renal failure, Turner syndrome, or Prader-Willi syndrome, or for children small for gestational age or with idiopathic short stature.
* In adults, GH can be legally distributed for only 2 conditions. The first is GH deficiency that meets the criteria of biochemical diagnosis (subnormal response to a GH stimulation test) and patients with GH deficiency alone or with multiple hormone deficiencies (hypopituitarism) or as a result of pituitary or hypothalamic disease, surgery, radiation therapy or trauma, or childhood GH deficiency.
* The second adult indication for HGH is wasting syndrome of AIDS, which does not include lipodystrophy.
"Antiaging" is NOT a legal reason to prescribe GH, regardless of dose. There is no proof it wards off aging and might even decrease lifespan (who knows for sure?). But if antiaging was legal then why couldn't a doc deem it beneficial to prescribe a higher dose? For example, say he thinks it reduces wrinkles better and the patient feels stronger and healthier at that dose.
From quick google search: