HGH quackery

HGH quackery refers to the fraudulent, unfounded, or exaggerated aspects of the claims, products, and businesses related to the use of growth hormone as an anti-aging therapy. Most of the HGH quackery falls into two categories:

1. Exaggerated, misleading, or unfounded claims that real growth hormone treatment slows or reverses the effects of aging
2. Sale of products that fraudulently or misleadingly purport to be growth hormone or to increase the buyer's own growth hormone to a beneficial degree.

The majority of products sold over the internet in association with the initials "HGH" are being sold in a misleading way.

Contents

1 Background on HGH and terminology 2 Adult growth hormone deficiency 3 Background on hormonal aspects of aging 4 The origin of the HGH industry: Rudman and Klatz 5 Unproven aspects of real GH use in aging adults 6 How these concepts are used misleadingly to market products on the internet 7 Links 8 References

Background on HGH and terminology

HGH and hGH refer to "human growth hormone." The reader may be curious as to why only this hormone is still often referred to as "human" when the term could obviously be appended to every hormone in the article Hormone. After three-letter abbreviations of amino acids were found so useful in the 1950s, endocrinologists in the 1950s tended to favor 3 letter abbreviations even for two-word hormones. At that time, most of the hormones available for administration, especially the proteins, were derived from animals. Most were similar, if not identical, to human hormones in structure and effectiveness.

However, animal growth hormones were relatively ineffective in humans because of structural differences. Human growth hormone purified from human pituitaries was a rare commodity used therapeutically between 1963 and 1984. The abbreviation hGH distinguished it from animal growth hormones in medical reports. When synthetic, human-sequence GH made by recombinant DNA technology replaced use of cadaver hGH in the mid-1980s, the term HGH no longer made sense, and endocrinologists largely stopped using the term for synthetic growth hormone. The abbreviation rGH can be used to refer to synthetic human-sequence growth hormone made by recombinant DNA technology, but to most endocrinologists, human growth hormone is simply "GH," whether measured in the blood or given by injection.

Adult growth hormone deficiency

The features of adult growth hormone deficiency include poor maintenance of lean body mass, with reduced muscle strength and diminished bone density. The reduced bone density can be severe enough to become osteoporosis. The body composition of GH-deficient adults tends to include a higher percentage of body fat. Cholesterol levels are higher, as is risk of cardiovascular disease. Subtler or more subjective problems include diminished mental and physical energy and resilience.

Children with early-onset hypopituitarism can grow up to become adults with growth hormone deficiency. Adults can become growth hormone deficient in a variety of ways (e.g., hypophysitis, surgery, head trauma, brain tumors).

The diagnosis is made by low IGF1 levels and poor responses to stimulation tests, as described in Growth hormone deficiency. Replacement of the deficient hormone rapidly reverses nearly all the effects of deficiency over a period of several months to 3 years, muscle strength and bone density improve, and body fat diminishes. Cholesterol falls, and IGF1 levels rise to normal. Results are gratifying and occasionally dramatic. Adverse events have been uncommon when low, replacement doses were given and more common when higher doses were used. The Growth Hormone Research Society issued a detailed report (http://jcem.endojournals.org/cgi/content/full/83/2/382) in 1998 of research on replacement of deficiency, and the American Association of Clinical Endocrinologists (http://www.aace.com) provides a concise overview (http://www.aace.com/clin/guidelines/hgh.pdf) of both diagnostic and treatment aspects of GH deficiency in adults and children. Ironically, only a fraction of severely deficient adults are willing to take growth hormone, due at least in part to high cost and distaste for injections. A more detailed history of GH use is provided in Growth hormone treatment.

Background on hormonal aspects of aging

Most of the changes of the human body after age 30 are unwelcome, and are referred to as aging. For all of recorded history, people have sought ways to slow the changes of aging.

In the context of putative anti-aging therapies, the most relevant body changes include diminished muscle mass and strength, bone strength and density, bone size, basal metabolic rate and calorie needs, elasticity of skin and connective tissue, rate of healing, libido and sexual performance, production of body fluids (tears, saliva, vaginal lubrication, joint fluids, etc.), and mental and physical energy, stamina, and resilience. Conversely, most older adults experience easier weight gain, narrowing of blood vessels and increased risk of cardiovascular disease, more rapid fatigability, and increased susceptibility to infection and cancer.

Hormones are involved in the development and maintenance of all of the desired characteristics of a youthful body. The effects of severe hormone deficiency, whether in a child or an adult, make these relationships obvious (see, for example, growth hormone deficiency, hypogonadism, hypothyroidism). Some of the hormonal changes that accelerate after age 40 or 50 in most people include slowly diminishing levels of steroid hormones like dehydroepiandrosterone and dehydroepiandrosterone sulfate, estradiol, and testosterone (Perry, 1999 (http://www.clinchem.org/cgi/content/abstract/45/8/1369)). On the other hand, sensitivity to insulin diminishes. Growth hormone and insulin-like growth factor 1 decline slowly with age.

The astute reader will have noticed how the features of adult growth hormone deficiency coincide with the features of aging. So is aging simply the result of declining growth hormone levels? Can it be halted by giving older people some extra growth hormone? Why not restore all hormone levels in elderly people to younger levels (Rinaldi, 2004 (http://emboreports.npgjournals.com/content/vol5/issue10/))?

The origin of the HGH industry: Rudman and Klatz

Although endocrinologists and other scientists interested in aging were asking this question as early as the 1970s and there were some uncontrolled and unpublished individual trials, the question became a subject of public interest due to two publications in the 1990s.

Rudman D, Feller AG, Nagraj HS et al (1990). Effect of human growth hormone in men over 60 years old. New Engl J Med 323:1-6. This famous paper from the prestigious New England Journal of Medicine reported real research by a real endocrinologist (Dan Rudman). It described modest improvements in some physical parameters such as bone density and muscle strength in 12 older men treated with high doses of real growth hormone for 6 months. Although the men were not severely GH deficient by standard criteria, the GH treatment increased their bone density and muscle mass and reduced their body fat. The paper was widely publicized in the mass news media, leading to much prediction that GH soon would be used routinely to slow aging in all of us. The paper is routinely cited by the sellers of products that are meant to be confused with growth hormone by the consumer. In many cases the paper is cited in such a way as to imply that Rudman was testing their product. In response to years of misuse and misrepresentation of this study, the New England Journal has posted the original study (http://content.nejm.org/cgi/content/abstract/323/1/1) online, along with commentary and further explanation.

In 1997, Dr. Ronald Klatz published Grow Young With HGH: The Amazing Medically Proven Plan To Reverse the Effects Of Aging (New York:Harper-Collins, 1997). It is an uncritical touting of GH as the answer to aging. Again, although fraud artists cite the book incessantly, Klatz was referring only to real growth hormone. Dr. Klatz wasn't a real endocrinologist or even a real M.D., but a D.O. with an M.D. degree purchased from Belize, perhaps because it enhanced the marketability of his book. Sellers of products with names including or suggesting HGH hope the consumer will think he was writing about their product. Klatz's book is a fine representative of a genre of books written for the public to proclaim the wonders of a newly available hormone. A classic example is The Male Hormone: A new gleam of hope for prolonging man's prime of life, written by Paul de Kruif (Garden City: Garden City, 1945). Its promotion of testosterone for Everyman is strikingly similar to the GH claims. Similar books have been written about estrogen and even DHEA. Only the hormones change-- the claims continue to be the desiderata of everyone past 50: vigor, energy, strength, slimness, protection from heart disease, et cetera.

Unproven aspects of real GH use in aging adults

The Rudman study attracted much public attention. A number of scientific studies attempted to replicate and address the questions raised by the Rudman study. In general, the studies have shown less impressive benefit and considerably higher rates of side effects when growth hormone has been given to older but non-deficient adults. These reports were less interesting to the news media.

For example, Blackman's better controlled trial (Blackman, 2002 (http://jama.ama-assn.org/cgi/content/abstract/288/18/2282)) of 6 months of growth hormone in 29 women and 36 men confirmed mild improvement in lean body mass but found far higher rates of diabetes, joint pain, fluid retention, and carpal tunnel syndrome in those receiving growth hormone than in 56 controls. Furthermore, the increased muscle mass was not accompanied by increased strength or improved function. As pointed out by Vance in a review of 13 years of these trials (Vance, 2003 (http://content.nejm.org/cgi/content/full/348/9/779)), an exercise program could provide greater benefits with reduced, instead of increased, risk.

Nevertheless, the number of "anti-aging clinics" in the United States increased substantially. Entrepreneurial physicians and others discovered plenty of wealthy people willing to pay thousands of dollars a month for unproven combinations of vitamins, dietary supplements, and hormones, including growth hormone. Some of the "longevity" clinics have been profiled on investigative television shows and are described (http://www.quackwatch.org/01QuackeryRelatedTopics/hgh.html) by Stephen Barrett on his Quackwatch website. For those of a more "do-it-yourself" bent, a number of websites aid the consumer in obtaining real growth hormone in Mexico or from offshore sites like China. As for any expensive products, counterfeit growth hormone with realistic packaging has been reported.

How these concepts are used misleadingly to market products on the internet

These two publications were enough to create a market for growth hormone, though many potential consumers were deterred by several-times-a-week injections costing many thousands of dollars a year. Internet quacks and fraud artists stepped in to fill the gap with less expensive, non-injectable products that are marketed in a misleading way (Perls, 2004 (http://biomed.gerontologyjournals.org/cgi/content/abstract/59/7/B682)). To keep within the letter, if not spirit, of truth-in-advertising laws, these products have been generally marketed as "HGH", "HGH releasers", or "homeopathic" HGH.

The following are indicators that a specific product is not synthetic growth hormone and may offer no objectively measurable benefits.

1. The product is referred to as "HGH". No one is currently using real human growth hormone, and those who make and prescribe synthetic growth hormone (somatropin) do not refer to it as HGH. In fact, initials can mean anything the maker of the product wants them to mean.
2. The sales pitch refers to Rudman's paper or Klatz's book (both described in detail above). Both are routinely cited by internet websites selling products with names suggesting "HGH". Dr. Rudman has no connection with these products and was using real GH. Dr. Klatz' book is an uncritical touting of GH as the answer to aging and can be criticized on many grounds, but he also was referring only to real growth hormone. Sellers of products with similar names hope the consumer will think Rudman and Klatz were writing about their products.
3. The prescriber of the product is not an endocrinologist. While in the US it is legal for any physician to prescribe GH, many insurance companies will decline to cover it unless it is prescribed by an endocrinologist. This is also true in practice or by regulation for the national health services of many other countries as well.
4. The prescriber or provider of the product is not basing the prescription on evidence of growth hormone deficiency such as low IGF1 levels and failure to respond to stimulation testing, and will not be monitoring levels during treatment. The most reliable indicator of probable objective benefit is that the person has GH deficiency by standard diagnostic criteria. People whose fatigue or flabbiness are not due to growth hormone deficiency are much less likely to respond to treatment with real GH.
5. The prescriber or provider of the product will not be monitoring anything during treatment. An endocrinologist will monitor a person receiving GH for both wanted and unwanted effects by measuring bone density, muscle strength, lipids, body composition, and/or levels of IGF1, glucose and insulin to avoid overtreatment.
6. No list of side effects is provided. Potential risks of GH at the right dose in deficient adults include temporary fluid retention, temporary joint or limb swelling or pain, and carpal tunnel syndrome. Non-physical disadvantages include insurance or employment problems related to an expensive medical condition, the nuisance of frequent injections, doctor visits, and blood tests, and perhaps the emotional stress of a long-term medical condition. The magnitude of potential benefit is reduced in persons who are not deficient, but the side effect risk rises. Risks of excessive amounts of GH for even a few months have included type 2 diabetes, while many more risks can be inferred from naturally occurring conditions of GH excess. In adults, excessive production of GH by the pituitary gland leads to a condition known as acromegaly. Connective tissue thickens and becomes less flexible. Skin is thickened, with increased production of oil and sweat. Lips, nose, tongue, brow ridges, and jaw can grow, distorting facial appearance. Larger nasal sinuses can lead to recurrent sinusitis. Nerves and joints can be damaged leading to pain, tingling, or reduction of sensation or reflexes in the legs or arms. In some cases, the muscles become abnormally weak. The person becomes less sensitive to insulin, which sometimes results in type 2 diabetes. The death rate for persons in their 40s with acromegaly is approximately twice expected. The likelihood of these acromegalic effects is minimal when replacement doses are given to deficient people, but rises with excessive amounts given to people who are not deficient. Finally, there is evidence that prolonged elevation of IGF1 levels may actually increase risk of prostate and other cancers in elderly adults. The only products that have no side effects are those that have no effects at all, such as the homeopathic preparations that contain infinitesimal amounts.
7. The product is not FDA-approved and does not require a prescription. This means that the maker of the product does not want to submit research studies to the FDA which demonstrate safety and efficacy, does not want his manufacturing process to be regulated by stringent FDA rules, and does not want to adhere to stricter rules about the contents of the product and the truthfulness of the labelling. In the U.S., this is often referred to as "health freedom" by purveyors of substances marketed as "dietary supplements".
8. The cost is not thousands of dollars a year. If it doesn't cost this, it's not GH. If a person is not deficient, he doesn't need it. The brands of real GH are expensive products with high profit margins.
9. The offer is accompanied by a multilevel marketing pitch. The consumer should be wary of companies that are more interested in getting them to sell the product than buy it. See MLMWatch (http://www.mlmwatch.org/) for more information.
10. The product is available as a nasal or oral spray, drops, pills, skin lotion, or aromatic oil. There was a lotion called something like KH3/GH10 marketed with implied promises of GH benefits: it claimed that it contained GH precursors to be rubbed into the skin of any body part that the consumer wished to make bigger. These are not growth hormone. GH, like other protein hormones, is digested in the stomach and effective amounts can only be gotten into the body by injection. If any of the major companies who compete for a share of the growth hormone market could devise an effective oral or nasal alternative, they would quickly dominate the market. No one would prescribe GH injections for children if there were an alternative.
11. The offer refers to the product as "natural". In the world of alternative medicine and health fraud, "natural" simply means "can be sold by someone who isn't licensed to write prescriptions." The health food shops, vitamin stores, and alternative boutiques call everything "natural", even if it's made in a factory. Ironically it's a downright frightening claim in relation to GH. The last truly natural GH was the human GH extracted from pituitary glands collected by pathologists at autopsies from the 1960s to the early 1980s. In 1984 it was discovered that a few people had contracted Creutzfeldt-Jakob disease, a "natural" but fatal prion infection similar to mad cow disease. This example alone should induce mistrust of anyone who claims natural is a synonym for safe.
12. It is described as "homeopathic growth hormone." Real growth hormone is expensive, about $10 to $100 a day, depending on the dose needed. What if a marketer bought 1 vial of GH and dissolved it in a thousand gallons of water, divided it into little bottles and called it homeopathic GH? If it were dissolved into so much water that no amount could be detected, it wouldn't have to be registered with the FDA, and if it were marketed it to people who didn't need real GH, no harm would be done (except to their bank accounts). A fuller explanation of homeopathy can be found at Quackwatch (http://www.quackwatch.com/01QuackeryRelatedTopics/homeo.html).
13. The product contains amino acids described as "releasers". This claim is pretty clever. Several of the amino acids, if given by mouth or by IV, can induce the pituitary gland to release a burst of GH. This phenomenon is exploited in diagnostic testing for GH deficiency. Intravenous administration of arginine usually produces a brief rise in the blood level of GH in healthy people. A person with GH deficiency will usually fail to respond. A low-budget version of this test used for years in England was the Bovril stimulation test. Bovril was a brand of beef bouillon that had enough amino acids to induce a brief GH rise in most children. People with GH deficiency cannot be treated with amino acids to increase their GH because their pituitaries don't respond well to them. On the other hand, those whose pituitaries will respond to amino acids are not deficient, and are unlikely to benefit from more GH. Furthermore, the GH rise after amino acids only lasts about 20 minutes, and diminishes with repeated doses or concurrent carbohydrate consumption. Nevertheless, clever marketers have found gold in these facts by marketing cheap waste protein (like connective tissue collagen remaining on cow carcasses after the meat is removed) as "natural GH releasers". Such marketers say their claimes are not dishonest because (a) amino acids do increase GH levels in most people, (b) more GH helps deficient people be younger, slimmer, more energetic, etc, (c) this protein does contain amino acids. Omitted from this not-quite-compelling syllogism are the facts that (a) the amount of extra GH produced by daily use of their product is quite small and lasts about 20 minutes, (b) no benefit has ever been demonstrated from transient, slightly increased amounts of GH in non-deficient people, (c) no benefit has ever been demonstrated from their products, and (d) some beef bouillon or canned tuna would be much cheaper and just as effective.
14. The product contains amino acids described as "precursors". The "precursor" claim is even more misleading. All proteins, including GH, are strings of amino acids, derived ultimately from dietary protein. Therefore, any amino acids eaten, whether from a pill, a hamburger, or hydrolyzed cow carcass collagen, just might end up in a GH molecule. That meets the definition of precursor and keeps the marketers just this side of fraud laws. A critic might point out that if someone is willing to pay $10 an ounce for protein, he might as well buy a good steak.
15. The sales pitch contains a message such as "this information and product are not intended to diagnose or treat any disease." This statement is usually the most truthful statement in the entire sales pitch. Believe it.

Links

The following links are examples of commercial sites that sell products or link to other marketing sites. All of the above cautions should be assumed applicable here.

QualityCount.com (http://www.qualitycounts.com/fpgrowthhormone.html) is a several-year-old commercial site with an excellent collection of links to examples of nearly all of the above products and practices.

Another commercial site (http://www.hgh.ws/) willing to explain just what's wrong with all the competing products.

Anti-aging site (http://www.worldhealth.net/) with links to all the questionable products, sites, and entrepreneurs described in much more detail by Barrett's Quackwatch site (http://www.quackwatch.org/).

References

[1] (http://www.aace.com/clin/guidelines/hgh.pdf) AACE Growth Hormone Task Force. American Association of Clnical Endocrinlogists Medical Guidelines for Clinical Practice for Growth Hormone Use in Adults and Children- 2003 Update. Excellent synopsis of current standards of care for diagosis and treatment of GH deficiency.

[2] (http://jama.ama-assn.org/cgi/content/abstract/288/18/2282) Blackman MR, Sorkin JD, Münzer T, Bellantoni MF, Busby-Whitehead J, Stevens TE, Jayme J, O'Connor KG, Christmas C, Tobin JD, Stewart KJ, Cottrell E, St. Clair C, Pabst KM, Harman SM (2002). Growth hormone and sex steroid administration in healthy aged women and men: a randomized controlled trial. J Am Med Assoc (JAMA) 288:2282-2292. This is the best controlled of the more recent trials of GH use for non-deficient elderly adults.

[3] (http://biomed.gerontologyjournals.org/cgi/content/abstract/59/7/B682) Perls TT (2004). Anti-aging quackery: human growth hormone and tricks of the trade? more dangerous than ever. J Gerontol A Biol Sci Med Sci.2004; 59: 682-691. Perls provides an excellent overview of the HGH scams, as well as his own 15 indicators of quackery (different-- more general). This article must be obtained through a medical library or purchased online.

[4] (http://www.clinchem.org/cgi/content/abstract/45/8/1369) Perry H (1999). Endocrinology of aging. Clin Chem 45:1369-1376. This is a concise review of the hormonal changes of normal aging.

[5] (http://emboreports.npgjournals.com/content/vol5/issue10/) Rinaldi A (2004). Hormone therapy for the ageing: despite the negative results of recent trials, hormone replacement therapy retains enticing promises for the elderly. EMBO Reports 5:938-941. This journalistic overview of recent and ongoing hormone replacement trials for aging must be obtained through a medical library or purchased online.

[6] (http://content.nejm.org/cgi/content/abstract/323/1/1) Rudman D, Feller AG, Nagraj HS et al (1990). Effect of human growth hormone in men over 60 years old. New Engl J Med 323:1-6. This was the original report that set off the public interest in GH treatment of aging.

[7] (http://jcem.endojournals.org/cgi/content/full/83/2/382) Report from the Scientific Committee of the Growth Hormone Research Society: Carroll PV, Christ ER, and the members of the Scientific Committee of the Growth Hormone Research Society: Bengtsson BA, Carlsson L, Christiansen JS, Clemmons D, Hintz R, Ho K, Laron Z, Sizonenko P, Sönksen PH, Tanaka T, Thorner M (1998). Growth hormone deficiency in adulthood and the effects of growth hormone replacement: a review. J Clin Endocrinol Metab 83:382-95. This is a detailed compilation of results of clinical research trials of GH replacement in deficient adults.

[8] (http://content.nejm.org/cgi/content/full/323/1/52) Vance ML (1990). Growth hormone for the elderly? New Engl J Med 323:52-4. This editorial accompanied Rudman's original report.

[9] (http://content.nejm.org/cgi/content/full/348/9/779) Vance ML (2003). Can growth hormone prevent aging? New Engl J Med 348:779-80. This is a brief but good summary of the research to date.