Human Growth Hormone Still Hyped for Anti-aging Benefits

Jan. 10, 2006 - Can growth hormone reverse the aging process? As long as that question is out there, hucksters will keep selling human growth hormone (HGH) to aging Americans, who are grasping for a youth that has slipped away. NBC's Today Show this morning featured Dr. Judith Reichman providing medical and legal information about this hormone, and various formulations and growth hormone substitutes that are sold by the multi-billion dollar anti-aging industry.

(More on the Today Show report – click here.)

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Also today, as is the case on almost every day, there are news releases hitting the wires telling about some new advance or development involving human growth hormone. After all, there truly would be a gold mine in a medicine that could positively reverse the aging process.

And there are warnings by the FDA of illegal drugs being sold with HGH and often the FTC is shutting down some scam artist that is making a fortune targeting senior citizens with products supposedly containing HGH.

HGH seems to be everywhere, even though current law explicitly prohibits the distribution except for clearly and narrowly defined indications. The distribution of HGH enhanced products for other uses, such as, anti-aging, age-related conditions, or enhancing athletic performance, are illegal.

Despite congressional hearings warning of deceptive marketing claims and the potential health and economic dangers associated with the anti-aging industry, and statements issued by the National Institute on Aging and the Federal Trade Commission, the distribution and use of GH for anti-aging is now common, said a study reported in the October 26, 2005, issue of JAMA..

Entering the terms "HGH" and "anti-aging" into the Google search engine generated 3,410,000 hits as of September 26, 2005, many representing Web sites and clinics marketing and selling GH, report the authors Thomas T. Perls, MD, MPH; Neal R. Reisman, MD, JD; S. Jay Olshansky, PhD.

The distribution and marketing of human growth hormone (HGH or GH) via Web sites and anti-aging clinics has grown into a multimillion-dollar anti-aging industry.

Worldwide annual sales of GH are estimated to be $1.5 to $2 billion.

An earlier JAMA article suggested that 30% of GH prescriptions in the United States are for reasons not approved by the Food and Drug Administration (FDA), which would include anti-aging and athletic enhancement.

In 2000, it was reported that an anti-aging industry source said that 30,000 people were receiving injectible GH for anti-aging at the time.

United States officials reportedly estimated that 25,000 to 30,000 older individuals were treated with GH for anti-aging in 2004.

In 2002, one anti-aging clinic reported that one third of its 4000 patients were spending $400 to $500 per month for GH injections.

IMS Health, a specialist in drug use in the U.S., indicated that a total of 212,921 new and refill GH prescriptions were filled by retail and mail service pharmacies in 2004 (Brian Palumbo, written communication, IMS Health, April 2005).

These prescriptions generated total sales of approximately $622 million ($427 million via mail services and $9.5 million via clinics), constituting 89% of sales for the class of drugs "anabolic hormones" (this class, for market surveillance purposes, includes GH).

Of these GH prescriptions, 74% were for individuals aged 20 years and older and 43.7% were for individuals aged 40 to 59 years.

These sales and prescription figures include legal prescribing for adult GH deficiency (GHD) and AIDS wasting syndrome, but do not include distribution of GH from anti-aging Web sites.

In 2002, physicians within the anti-aging industry estimated that 100,000 individuals obtained the drug without a prescription.

A nonsystematic view by the researchers of numerous Web sites revealed that the cost of pills and sprays allegedly containing GH is substantial, with both costing the consumer as much as $200 to $300 for what marketers indicate as a month’s supply. By contrast, the injectible form of GH typically costs from $500 to $1,000 per month.

What does HGH Do

"Growth hormone has been documented to improve some measures of body composition, including increased muscle mass, reduced total body fat, improved skin elasticity, and reduced rate of bone demineralization, but without positive effects on strength, functional capacity, or metabolism," according to the JAMA report

"Furthermore, the positive effects may be short-lived: in a study of 148 patients with adult GHD, the modest beneficial effects on body composition (eg, 5% increase in lean body mass) disappeared for most individuals after 24 months of treatment, and 38% of study participants dropped out because of lack of subjective improvement.

"In addition, the healthy lifestyle that patients who receive injectible GH are often encouraged to adopt, rather than the GH itself, may contribute to changes in body composition."

Growth hormone is associated with substantial adverse effects, too, say the authors..

"Proponents of GH claim that aging is caused by an age-related decline in GH levels and therefore GH supplementation can stop or reverse aging," the article says.

"But scientific findings counter or fail to support this hypothesis."

Transgenic mice that produce supraphysiological levels of GH for their age have

In adults, the FDA has stated that distribution of GH is legal for only 2 conditions: wasting syndrome of AIDS and GHD, the latter of which must meet specific diagnostic criteria.

In the United States, GH is commonly marketed, distributed, and prescribed for anti-aging under the pretext of "off-label use." However, off-label distribution or marketing of GH to treat aging or aging-related conditions is illegal.

Unlike most FDA-approved medications, GH can only be distributed as authorized by the Secretary of Health and Human Services and aging and its related disorders are not authorized uses. The penalties for distribution or provision of GH for anti-aging purposes are substantial.

Furthermore, the FDA has clearly indicated that GH is not a dietary supplement, but is a drug.

"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," write the study authors.

The also recommend that "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."

They also suggest that "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 anti-aging."

Corresponding Author: Thomas Perls, MD, MPH, Geriatrics Section, Department of Medicine, Boston Medical Center, Robinson 2400, 88 E Newton St, Boston, MA 02118

Disclosure: Drs Perls and Olshansky report that they are defendants in a lawsuit brought against them by the American Academy of Anti-Aging Medicine and others.

Funding/Support: Dr Perls is a Paul Beeson Career Development Award in Aging Research awardee (The American Federation of Aging Research and the Alliance for Aging Research) and funds from Boston University School of Medicine’s Evans Medical Foundation supported a portion of this work. Dr Olshansky was supported by award K02 AG00785-05 from the National Institute on Aging.

Author Affiliations: Geriatrics Section, Department of Medicine, Boston Medical Center and Boston University School of Medicine, Boston, Mass (Dr Perls); Department of Plastic Surgery, Baylor College of Medicine, and St Luke’s Episcopal Hospital, Houston, Tex (Dr Reisman); School of Public Health, University of Illinois at Chicago, Chicago, Ill (Dr Olshansky).

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