Provision or distribution of growth hormone for "antiaging": clinical and legal issues.

THE DISTRIBUTION AND MARKETING OF HUMAN GROWTH hormone (HGH or GH) via Web sites and antiaging clinics has grown into a multimillion-dollar antiaging industry. Despite congressional hearings warning of deceptive marketing claims and the potential health and economic dangers associated with the antiaging industry, and statements issued by the National Institute on Aging and the Federal Trade Commission, the distribution and use of GH for antiaging is now common. For example, 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. Worldwide annual sales of GH are estimated to be $1.5 to $2 billion. Vance has suggested that 30% of GH prescriptions in the United States are for indications not approved by the Food and Drug Administration (FDA), which would include antiaging and athletic enhancement. In 2000, Langreth quoted an antiaging industry source as stating that 30 000 people were receiving injectible GH for antiaging at the time. United States officials reportedly estimated that 25 000 to 30 000 older individuals were treated with GH for antiaging in 2004. In 2002, one antiaging clinic reported that one third of its 4000 patients were spending $400 to $500 per month for GH injections. While precise figures on total GH distribution and use cannot be obtained, to estimate annual GH distribution in the United States, we contacted IMS Health (Fairfield, Conn), an independent pharmaceutical industry research company. IMS Health projects total national sales and prescription totals from a computerized panel of 22 000 retail pharmacies, including chain pharmacies, independents, mass merchandisers, and food store–based pharmacies, representing approximately 45% of the total prescription sales for the US retail market. IMS Health also collects information from approximately 50 mail service outlets representing 70% of the US mail service market (Brian Palumbo, written communication, IMS Health, April 2005). Information from IMS Health indicates 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) (Brian Palumbo, unpublished data, IMS Health, 2005). 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, defined below) and AIDS wasting syndrome, but do not include distribution of GH from antiaging Web sites. In 2002, physicians within the antiaging industry estimated that 100 000 individuals obtained the drug without a prescription. Prescribing and administering GH has become a routine intervention in an industry that is variably called “antiaging,” “regenerative,” “longevity,” or “age-management” medicine, although not all physicians using these designations administer GH to their patients. A nonsystematic viewing 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 (T.H.P., unpublished data, 2005). By contrast, the injectible form of GH typically costs from $500 to $1000 per month.