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Endocrine Society Raises Concerns to U.S. House Committee about Potential Risks of HGH Off-Label Use
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Endocrine Insider Dr. Alan Rogol, an Endocrine Society member and professor of clinical pediatrics at the University of Virginia and the Indiana University School of Medicine, testified on behalf of the Society before the U.S. House of Representatives Committee on Oversight and Government Reform on February 12, 2008, about the clinically acceptable uses for human growth hormone (HGH) and the potential risks of off-label use. The hearing focused on the myths and facts surrounding HGH, vitamin B12, and other substances, and was a continuation of a series of hearings that the committee has held across the past three years on the use of these substances by athletes and consumers to improve performance and slow down the aging process. The committee’s primary focus during Tuesday’s hearing was to understand the medical uses for HGH and vitamin B12 and any potential risks of off-label uses of these substances. The hearing was held in preparation for future hearings that examine real-life cases of off-label HGH use. The testimony of the majority of witnesses at the hearing reflected the medical community’s belief that off-label use of HGH comes with increased risk. Dr. Rogol’s testimony touched on the medically accepted uses for HGH—which include treatment of growth hormone deficiency, Turner syndrome, and idiopathic short stature—but focused on the potential risks associated with off-label use of the hormone. He mentioned that while increased doses of legitimate and safe HGH could result in the serious side effect of acromegaly, it is unlikely that self-medicated users have access to and can afford pure HGH in amounts required to produce this effect. Dr. Rogol emphasized that many non-FDA approved products marketed as HGH may include undisclosed components, including steroid hormones, that may have unintended consequences. Indeed, many of these products are taken orally, an ineffective route of administration for HGH. Thus, users of these products are likely not benefiting from any HGH that may be present, but may very well be increasing their risk for unintended effects of contaminating ingredients. Dr. Rogol raised the concern that even if unregulated products are pure HGH and are taken by the effective intravenous route, the preparation may be of human origin (rather than recombinant DNA as is used to produce most FDA-approved HGH), placing the user at risk of contracting the rare but fatal Creutzfeldt-Jakob disease. Furthermore, Dr. Rogol stated that long-term use of HGH may promote tumor growth. Other witnesses—whose testimony focused largely on the use of HGH to slow or reverse the aging process and the role of vitamin B12 in enhancing physical performance—included Dr. Susan Shurin, Deputy Director, National Heart, Lung, and Blood Institute, National Institutes of Health; Dr. Thomas Perls, Associate Professor of Medicine and Director, New England Centenarian Study, Boston University School of Medicine; and Dr. Todd Schlifstein, Department of Rehabilitation Medicine, Hospital for Joint Disease. You may read Dr. Rogol’s testimony in its entirety at the following link: |
