Growth Hormone Schemes and Scams

Human growth hormone (HGH) is a substance secreted by the pituitary gland that promotes growth during childhood and adolescence. Growth hormone acts on the liver and other tissues to stimulate production of insulin-like growth factor I (IGF-I), which is responsible for the growth-promoting effects of growth hormone and also reflects the amount produced. Blood levels of circulating IGF-I tend to decrease as people age or become obese [1]. Many marketers would like you to believe that boosting HGH blood levels can reduce body fat; build muscle; improve sex life, sleep quality, vision and memory; restore hair growth and color; strengthen the immune system; normalize blood sugar; increase energy; and "turn back your body's biological clock." This article traces the history of these claims and why you should disregard them.

Marketing "Milestones"

The drive to popularize growth hormone began about 20 years ago with publication of the book Life Extension: A Practical Scientific Approach, by Durk Pearson and Sandy Shaw [2]. The book's central premise was large amounts of vitamins, minerals, amino acids, and and other substances would cause people to add muscle, burn fat, and live much longer. Although their advice had no scientific basis [3,4], Pearson and Shaw made hundreds of talk-show appearances that boosted sales of the substances they recommended.

Soon after the book's publication, many amino acid products were claimed to cause overnight weight loss by increasing the release of growth hormone. So called "growth-hormone releasers" were also marketed to bodybuilders with claims that they would help build muscle. Such claims are unfounded because amino acids taken by mouth do not stimulate growth hormone release. These formulations are based mainly on misinterpreted studies of intravenous arginine, which can increase HGH blood levels for an hour or so. Taking it by mouth has no such effect. The FTC [5-9], and the New York City Department of Consumer Affairs [10] attacked some companies making "growth-hormone release" claims, but these actions had very little effect on the overall marketplace.

In 1990, The New England Journal of Medicine published a study that attracted mainstream media attention. The study involved 12 men, aged 61 to 81, who were apparently healthy but had IGF-I levels below those found in normal young men. The 12 men were given growth hormone injections three times a week for six months and compared with 9 men who received no treatment. The treatment resulted in a decrease in adipose (fatty) tissue and increases in lean body (muscle) mass and lumbar spine density [11]. An accompanying editorial warned that some of the subjects had experienced side effects and that the long-range effects of administering HGH to healthy adults were unknown. It also warned that the hormone shots were expensive and that the study had not examined whether the men who received the hormone had substantially improved their muscle strength, mobility, or quality of life [1].

Despite the warning, the study inspired many offbeat physicians to market themselves as "anti-aging specialists." Many such physicians offer expensive tests that supposedly determine the patient's "biological age," which they promise to lower with expensive hormone shots and dietary supplements. In 2001, NBC's Dateline showed what happened when a 57-year-old woman visited a Cenegenics clinic in Las Vegas, Nevada, where she underwent $1,500 worth of tests and was offered a hormone and 40-pill-a-day supplement program that would cost $1,500 a month. She was told that although she tested at "age 54,"her hormone levels were "sub-optimal" and that optimal would be the level of a 30-year -old [12].

The 1990 article also helped stimulate formation of the American Association for Anti-Aging Medicine (A4M) and the unrecognized medical specialty of "anti-aging medicine." A4M, which was founded in 1993, now reports that it has over 26,000 members, of whom 85% are physicians. Many exhibitors at its conferences have made questionable claims for HGH-related products.

The Internet has added another dimension to the HGH marketplace. Thousands of Web sites and spam e-mailers are hawking the actual hormone; alleged HGH releasers; alleged oral hormone products (which can't work because any HGH would be digested); and/or "homeopathic HGH" products.

Caution Needed

HGH is useful for treating growth hormone deficiency in children and adults and has several other proven (FDA-approved) uses [13]. But the American Association of Clinical Endocrinologists has warned that the clinical use of growth hormone as an anti-aging treatment or for patients with ordinary obesity is not recommended [14].

Robert N. Butler, M.D., the noted gerontologist who founded and headed the International Longevity Center-USA warned that, "So-called anti-aging medicine is largely a sham. We simply do not have the equivalent of a blood pressure cuff for testing aging." He further stated:

Although growth hormone levels decline with age, it has not been proven that trying to maintain the levels that exist in young persons is beneficial. It is conceivable that age-related hormonal changes may serve as useful markers of physiological aging. However, this has not been demonstrated experimentally for either humans or animals. Although hormone-replacement trials have yielded some positive results (at least in the short term), it is clear that negative side effects can also occur in the form of increased risk for cancer, cardiovascular disease, and behavior changes.

It might even turn out that lower growth-hormone levels are an indicator of health. Research findings indicate that mice that overproduce growth hormones live only a short time, suggesting that growth-hormone deficiency itself does not cause accelerated aging, but that the opposite may be true. . . .

Doctors who claim to have the ability to measure "biomarkers of aging" and favorably affect them are not scientifically-based [15].

In March 2003, the New England Journal of Medicine took the unprecedented step of denouncing misuse of Rudman's 1990 article. The full text of the article was placed online so readers could see for themselves what it actually said; and editorials pointed out that subsequent reports provide no reason to be optimistic. As noted by Editor-in-Chief Jeffrey M. Drazen, M.D.:

Although the findings of the study were biologically interesting, the duration of treatment was so short that side effects were unlikely to have emerged, and it was clear that the results were not sufficient to serve as a basis for treatment recommendations. . . . Indeed, Mary Lee Vance of the University of Virginia said in an accompanying editorial, "Because there are so many unanswered questions about the use of growth hormone in the elderly and in adults with growth hormone deficiency, its general use now or in the immediate future is not justified." Dr. Vance restates her views on the study in this issue of the Journal; they remain fundamentally unchanged. . . .

We are especially concerned because the promotional e-mails are apparently sending readers to our Web site; the 1990 article by Rudman et al. receives as many "hits" in a week as other 1990 articles do in a year. If people are induced to buy a "human growth hormone releaser" on the basis of research published in the Journal, they are being misled. In order to warn those who visit our Web site for this reason, this Perspective article and Dr. Vance's commentaries will from now on appear with the article by Rudman et al. each time it is downloaded [16].

Citing several studies of HGH injections in which side effects were significant [17-19], Vance concluded:

Studies that have followed the 1990 report by Rudman et al. confirm the effects of growth hormone on body composition but do not show improvement in function. In contrast, resistance training improves muscle strength and function, indicating that real effort is beneficial. There is no current "magic-bullet" medication that retards or reverses aging [20].

Here are portions of two ads that promoted dubious HGH ;products:

Enforcement Actions

In January 2003, the FDA sent a warning letter to Be Youthful, of Edmonton, Canada, objecting to claims that their Be Youthful HGH product was effective against depression, chronic fatigue, high blood prsessure, and high cholesterol levels [21].

In April 2003, Nature's Youth, LLC, of Centerville, Massachusetts, voluntarily destroyed approximately 5,700 boxes of "Nature's Youth HGH" with a market value of about $515,000. The destruction took place after the FDA notified the company that claims made for the product were unsubstantiated and therefore illegal. The company had claimed that the product, which it described as a growth-hormone releaser, would enhance the body's natural production of Human Growth Factors and Insulin-like Growth Factor-1; improve physical performance; speed recovery from training; increase cardiac output; and increase immune functions; and was "your body's best defense against aging." [22].When asked for substantiation, the company cited Rudman's 1990 report, which, as noted above, does not support such claims. The product's leading promoter has been G. Gordon Liddy, the former Watergate conspirator who served five years in prison and now hosts a talk show syndicated to 160 radio stations. In 2002, Nature's Youth's Web site carried a testimonial from Liddy:

I am often asked my secret for remaining virile, vigorous, potent and fecund. The secret is that, in addition to not smoking or drinking alcohol, exercising and following a diet low in calories, fat and red meat and high in fish, I have for some time been taking a Human Growth Hormone Releasant specially formulated for me and heretofore not available to the public. Now, under the brand name Nature's Youth HGH, the exact formula I have been using is available to you. My secret is out. Nature's Youth HGH is how I stay "Good to Go and Ready to Launch! [23]

In 2007, the College Pharmacy, of Colorado Springs, Colorado, its owner (pharmacist Thomas Bader), a sales representative (Kevin Henry), and a sales representative (Bradley Blum) from a company in Houston, Texas, were indicted by a federal grand jury for illegally importing and distributing HGH from China. The indictment charged that the defendants obtained Chinese-manufactured HGH that lacked FDA approval and repackaged and sold it to physicians throughout the United States. In response to the indictment, the Colorado Board of Pharmacy revoked Bader's license [26]. Blum subsequently pleaded guilty and was fined $10,000 and placed on 2 years probation. In 2008, the U.S. Government and the pharmacy owners reached a civil agreement under which $3.5 million (representing the proceeds from illegal importation and sale of HGH) was forfeited [27]. For many years, the College Pharmacy catalog identified it as "one of the largest, most comprehensive compounding centers in North America." In 2005, it was fined $50,000 and placed on probation following complaints that its pharmacists had incorrectly dispensed medication.

In 2009, Sean Shafer and The Compounding Center, Inc.,of Phoenix, Arizona were charged with illegally distributing HGH. The indictment alleged that the company's Web site touted impermissible uses of HGH for "anti-aging" purposes and that from 2001 through 2006, nine doctors made more than 400 purchases totaling more than $1.1 million. The indictment also states that Shafer, in his capacity as the manager of the wholesale department of the Compounding Center, also sold a number of HGH kits to two undercover operatives who specifically told him that the purchases were for bodybuilders and athletes [29].

In 2011, Linda Bunch, M.D., who practiced in Monroe, Louisiana, pleaded guilty to conspiring to import and distribute HGH. The indictment charged that she had conspired with a chiropractor to import the drug from China for an unapproved use [30]. In 2012, she was sentenced to 27 months in prison and ordered to forfeit $200,000. Bunch then tried to change her plea, but the District Court judge denied the request and also refused to delay imprisonment while she appeals further.

The State of Washington's Medical Quality Assurance Commission (MQAC) has disciplined at least four physicians and one naturopath for advertising and/or prescribing HGH and/or other hormones for "anti-aging purposes:

In 2010, Kenneth M. Jones, M.D. signed agreed order under which his license was suspended for 30 days, after which he was placed on probation for five years. He was also fined $10,000 and permanently prohibited from promoting, prescribing, or otherwise providing thyroid hormones, human growth hormone, human chorionic gonadotropin, testosterone, or other anabolic steroids [31].

In 2012, Jerry N. Mixon, M.D. signed an agreed order that prohibited him from prescribing growth hormone and required him to (a) pay a $10,000 fine, (b) serve at least three years on probation, (c) take an approved ethics course, and (4) submit to semi-annual practice reviews [32].

In 2013, Janet Vondran, M.D., signed an agreed order agreed order under which she was (a) fined $3,000, (b) prohibited from advertising or prescribing hormone supplementation, and (c) placed on probation for at least 2 years during which she would be subject to semi-annual practice reviews [33].

In 2013, Bradford Weeks, M.D., was s fined $5,000 and his license was suspended for at least three years [33]. He has appealed the board's decision [34].

In 2015, the license of Edmund M. Corpuz, N.D. was indefinitely suspended after he failed to respond to charges that he had prescribed HGH for weight loss to people he had interviewed via Skype but never examined [35,36]. Six months later, he signed a consent order under which his license was reinstated but he was fined $1,800 and placed on probation for at least two years, during which time he was required to take specified continuing education courses and have his practiced monitored [37].

The Bottom Line

. So-called "growth-hormone releasers," oral "growth hormone," and "homeopathic HGH" products should be regarded as fakes.

References

Vance ML. Growth hormone for the elderly? New England Journal of Medicine 323:52-54, 1990.

Pearson D, Shaw S. Life Extension: A Practical Scientific Approach. New York: Warner Books, 1982.

Barrett S. Book Review: Life Extension: A Practical Scientific Approach. ACSH News and Views 4(5):14-15, 1983.

Yetiv JZ . Popular Nutritional Practices: A Scientific Appraisal. Toledo, Ohio: Popular Medicine Press, 1986, pp. 82-101.

Weider to pay at least $400,000 in consumer redress and research grants under Federal Trade Commission agreement. FTC News release, Aug 19, 1985.

Franchisor of food supplement stores prohibited from making false claims, under consent agreement with FTC. FTC News release, Jan 4, 1988.

General Nutrition Inc. agrees to pay $2.4 million civil penalty to settle charges it violated two previous FTC orders. FTC News release, April 28, 1994.

Nature's Bounty to pay $250,000 redress as part of settlement with FTC over supplement claims. FTC News release, April 27, 1995.

3,044 victims of weight-loss clinics fraud case to get partial refunds, following FTC law enforcement action. FTC News release, April 10, 1997.

von Nostitz G and others. Magic muscle pills!! Health and fitness quackery in nutrition supplements. New York City Department of Consumer Affairs, 1992.

Rudman D and others. Effects of human growth hormone on men over 60 years old. New England Journal of Medicine 323:1-6, 1990.

Time in a bottle? Dateline NBC, March 6, 2001.

American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for growth hormone use in adults and children—2003 update. Endocrine Practice 9-65-76, 2003.

AACE guidelines support proper use of growth hormone replacement therapy. American Association of Clinical Endocrinologists news release, Sept 9, 1999.

Butler RN. Some notes on "anti-aging" programs. Quackwatch

Drazen JM. Inappropriate advertising of dietary supplements. New England Journal of Medicine 348:777-778, 2003.

Vance ML. Retrospective: Can growth hormone prevent aging? New England Journal of Medicine 348:779-780, 2003.

Blackman MR and others. Growth hormone and sex steroid administration in healthy aged women and men: a randomized controlled trial. JAMA 288:2282-2292, 2002.

Papadakis MA and others. Growth hormone replacement in older men improves body composition but not functional ability. Annals of Internal Medicine 124:708-716, 1996.

Taaffe DR and others. Effect of recombinant human growth hormone on the muscle strength response to resistance exercise in elderly men. Journal of Clinical Endocrinology and Metabolism 79:1361-1366, 1994.

Foret JB. Cyber warning letter to Be Youthful. Jan 23, 2003.

Misbranded dietary supplements destroyed. FDA news relesase, May 1, 2003.

Nature's Youth Web site, accessed May 29, 2002.

Barrett S. "Anti-aging" doctor placed on probation. Casewatch Web site, July 9, 2006.

Indictment. United States of America v. Thomas Bader, Kevin Henry, Bradley Blum, and College Pharmacy, Inc., Aug. 2007.

Stipulation and final agency order. In the matter of disciplinary proceedings regarding the license of Thomas W. Bader, Oct 19, 2007

Judge orders Colorado Springs based College Pharmacy to forfeit $3,500,000. U.S. Attorney's Office, press release, Dec 19, 2008.

Barrett S. License revocation of Jerome N. Lentini, M.D. Casewatch, March 16, 2015.

Indictment. United States of America v. Sean Shafer and the Compounding Center. U.S. District Court, District of Arizona, June 17, 2009.

Bunch LC. Plea agreement. United States of America versus Linda C. Bunch. Case No. 3:10-cr-00198-01, Dec 9, 2011.

Barrett S. Disciplinary action against Kenneth M. Jones, M.D. Casewatch, Feb 23, 2015.

Barrett S. Disciplinary actions against Jerry Mixon, M.D. Casewatch, Feb 26, 2015.

Barrett S. Janet Vondran, M.D., ordered to stop prescribing growth hormone. Casewatch, Feb 23, 2015.

Barrett S. Disciplinary actions against Bradford Weeks, M.D. Casewatch, Feb 25, 2015.

Statement of charges. In the matter of Edmund M. Corpuz, N.D. Washington Board of Naturopathy Case No. M2013-1275, Filed Dec 9, 2014.

Findings of fact, conclusions of law, and final order of default (failure to respond). In the matter of Edmund M. Corpuz, N.D. Washington Board of Naturopathy Case No. M2013-1275, Feb 6, 2015.

Stipulated findings of fact, conclusions of law, and agreed order on reinstatement. In the matter of Edmund M. Corpuz, N.D. Washington Board of Naturopathy Case No. M2013-1275, Aug 28, 2015.