¶ 10:34 AMFuture of Medical Care at Risk: 16,500-Member Physician and Scientist Group in 80 Nations Strikes BackChicago (PRWEB) November 13, 2005 -- A recently published JAMA Commentary purported to address the legality of Human Growth Hormone (hGH, GH) treatment by physicians for adult growth hormone deficient (GHD) patients. The commentary was filled with incorrect, misplaced references and studies, and multiple basic scientific errors, in an apparent attempt to damage the Anti-Aging medical profession and the physicians practicing solid, evidence-based medical healthcare focused on improving patients' quality of life. The authors selected self-serving studies, in which they failed to qualify the conclusions in an effort to bolster their disinformation campaign.
They wrongfully intermingled internet sales of homeopathic pseudo "GH" sprays, amino acids, and sports nutritional over the counter products in order to inflate their misleading claims suggesting an illegal diversion of hGH by physicians and pharmacies, implying a black market in FDA approved prescription injectable hGH for hormone replacement treatments by anti-aging physicians where none exists. Biased, agenda based, inaccurately misrepresented data cannot be left unchallenged and is a threat to both patients and physicians who believe in freedom of choice in healthcare.
The authors of the JAMA commentary state that the positive effects of hGH "may be shortlived and state to our knowledge, no studies have assessed long-term efficacy or safety of GH administration as an anti-aging intervention in humans. There is ample peer review research in the medical literature demonstrating the positive benefits of this pharmaceutical agent in multi-year studies, well beyond the typical 6-12 month study protocols. Growth hormone replacement therapy has been shown to improve many quality of life concerns such as loss of muscle mass, strength and energy levels.
The study the authors use to bolster their side effect theories, has already been called to task in JAMA published rebuttals: the dosages (which are misrepresented by the JAMA commentary authors) far exceed the proper and usual dose commonly employed by physicians in clinical practice  with side effects noted on the order of 1 to 2%. Recent studies now cite the benefits of low dose HGH without mention of side effects seen with the supra-physiologic dosages. In spite of the JAMA commentary authors' statements regarding an increased cancer risk with hGH treatment, they failed to report supportive data.
Recent media reports about the federal law concerning hGH have created unnecessary confusion in the media, and some reporters have confused non-medical over-the-counter homeopathic sprays and nutritional products with pharmaceutical-grade, FDA-approved injection medications for adult growth hormone deficient (AGHD) patients. Misleading journalism incorrectly intermingles sports and homeopathic nutritional supplements sold through websites with pharmaceutical-grade injectable HGH prescribed for patients with diagnosed AGHD. Such poor presentations of the science and commentary, have erroneously suggested that the replacement of hGH in aging adults is illegal, and has led to sensationalized headlines. Patients are not given HGH for a diagnosis or treatment of "anti-aging," but for on-label use for AGHD syndrome, a diagnosed disease.
The federal law in question is 21 U.S.C. § 333(e), a provision of the Food, Drug, and Cosmetic Act (FDCA). It says, in pertinent part, that "whoever knowingly distributes, or possesses with intent to distribute, human growth hormone for any use in humans other than the treatment of a disease or other recognized medical condition, where such use has been authorized by [FDA] and pursuant to the order of a physician, is guilty of an offense punishable by not more than 5 years in prison." We need to take a critical look at the historical context and legislative intent of a law before we interpret it. The law did not originally address hGH. Although never even mentioned in the JAMA piece, the 1988 law was written and passed regarding anabolic steroids. The legislative history of the law's creation shows an intent to focus on steroid trafficking to athletes, particularly adolescent athletes, amid increasing reports of amateur and professional sports doping and concerns about the upcoming Seoul Olympics (at which, ironically, Canadian sprinter Ben Johnson's steroid positive ignited a global firestorm).
Two years later, in 1990, heightened alarm over steroids and hGH in athletics resulted in the Anabolic Steroid Control Act of 1990, which lifted steroids out of the FDCA and into the Controlled Substances Act. Congress was presented with the option of making hGH into a controlled substance, too. However, following expert medical testimony that hGH lacks the adverse psychological and physical effects of steroids, Congress chose not to take such a drastic approach to hGH. Instead, Congress took the lesser approach of inserting hGH, to replace steroids, in the FDCA law that was written to stop trafficking to cheating athletes. The focus of lawmakers and Congress has always been to address non-medical use again, improper use by competitive elite athletes, sports people and teenagers. One of the authors of the recent JAMA commentary stated to United Press International (UPI) in reference to the statute, "They basically put in language that made it crystal clear that it is illegal to use growth hormone as an anti-aging intervention". This is a very odd statement, considering the fact that when the law was written, there were no anti-aging doctors or profession in existence. In fact, the anti-aging medical profession did not even exist until 5 years after the 1988 statute was enacted.
Despite their hyperbolic rhetoric, the co-authors of the commentary admit that hGH prescribing is perfectly legal in connection with (1) "treatment of a disease" or (2) an "other recognized medical condition" that has been authorized by FDA. At no time has Congress evinced any intent to restrict ethical physicians from prescribing hGH to mature or elderly adults for medical reasons within their sound judgment. Nothing in the statute dictates to physicians how to diagnose the indications for diseases which may be treated by hGH. Any inference that the statute was intended to prohibit physicians from prescribing hGH for hormone replacement purposes in GH-deficient adults is misplaced. It is incumbent upon medical science writers to refrain from making biased or inflammatory statements, for agenda-driven science reporting is not scientific.
Two of the three authors of the JAMA commentary are defendants in a $120 million lawsuit brought against them by the American Academy of Anti-Aging Medicine (as well as other plaintiff parties) for defamation, slander, conspiracy, and other claims. The defendants' attempt to have the claims dismissed in court was recently denied by the court.
Most interesting of all is that the third article by the same Forbes journalist yet again promoting the work of the lead author of the commentary in JAMA, now has turned his attention to promoting Elixir Pharmaceuticals in a Forbes cover story entitled, Want to Live Forever barely a week after penning in the same publication, Jail Time for Growth Hormone. A curious section from this newest piece, written barely a week after the former, states: Elixir focuses on another molecular mechanism linked to aging, one that casts doubt on the fad of taking human growth hormone to keep you young. Mice engineered to be resistant to the effects of growth hormone or a related hormone, IGF-1, live longer than their normal counterparts, several studies have found; other mice bred to have elevated hormone levels die young. Elixir hopes to design drugs that block the effects of the natural hormone ghrelin, which prompts the release of growth hormone and stimulates appetite. The company aims to test this approach for diabetes and possibly obesity; it hopes to begin human trials in two years.. Most profound here, is this JAMA author failed to disclose that he is in fact one of the founders of Elixir Pharmaceuticals. Even further, a listed source for the Forbes article, is not surprisingly, the third author of the JAMA commentary.
HGH therapy has been in use for over 40 years on adults and children, with one of the best safety records in modern pharmacia and whose dose in adults is typically only ½ to 1/3 of the pediatric does and under the strict supervision of an endocrinologist or anti-aging specialist. Not a single death or permanent life threatening morbidity has been reported in its use of AGHD by these experts in otherwise healthy but AGHD patients.
The Academy and it global affiliates worldwide will stand with its members for the protection of health care freedoms for physicians and patients seeking the benefit of legitimate therapies for a longer and healthier life.
An expanded version of this Official Response, complete with reference citations, is online at:
http://www.worldhealth.net/p/anti-aging-hgh-20051111.html.
The American Academy of Anti-Aging Medicine, Inc. ("A4M") is a non-profit medical society dedicated to the advancement of technology to detect, prevent, and treat aging related disease and to promote research into methods to retard and optimize the human aging process. A4M is also dedicated to educating physicians, scientists, and members of the public on biomedical sciences, breaking technologies, and anti-aging issues. A4M believes that the disabilities associated with normal aging are caused by physiological dysfunction which in many cases are ameliorable to medical treatment, such that the human lifespan can be increased, and the quality of one's life enhanced as one grows chronologically older. A4M seeks to disseminate information concerning innovative science and research as well as treatment modalities designed to prolong the human lifespan. Anti-Aging Medicine is based on the scientific principles of responsible medical care consistent with those of other healthcare specialties. Although A4M seeks to disseminate information on many types of medical treatments, it does not promote or endorse any specific treatment nor does it sell or endorse any commercial product.
Source: The American Academy of Anti-Aging Medicine (A4M), Chicago, IL
Phone: (773) 528-4333
Fax: (773) 528-5390
Website: www.worldhealth.net
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Press Contact: Catherine Cebula
Company Name: AMERICAN ACADEMY OF ANTI-AGING MEDICINE (A4M)
Email: mediaGHD@a4minfo.net
Phone: 773-528-4333
Website: http://www.worldhealth.net/p/anti-aging-hgh-20051111.html
