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A Cochrane systematic study reviewed the benefits of testosterone for peri- and postmenopausal women. The authors concluded, "There is evidence that adding testosterone to hormone therapy has a beneficial effect on sexual function in postmenopausal women. There was a reduction in HDL cholesterol associated with the addition of testosterone to the hormone therapy regimens. Due to lack of targeted research, it is difficult to estimate the effect of testosterone on sexual function in association with any individual hormone treatment regimen."72
Rhoden et al. point out that benign prostatic hyperplasia (BPH) symptoms are not exacerbated with testosterone supplementation.22,73 Cooper et al. studied the effect of exogenous testosterone on prostate volume, serum, and semen prostate specific antigen (PSA) levels in healthy young men.74 Participants were given testosterone intramuscularly at doses of 100, 250, or 500 mg a week. Serum testosterone increased, and there was no change in prostate volume or serum and semen PSA. Morales and Prehn both concluded that there is no evidence to suggest that exogenous androgens promote the development of prostate cancer.75,76 Morley states, "There is no clinical evidence that the risk of either prostate cancer or BPH increases with testosterone replacement therapy."77 A collaborative analysis published in the Journal of the National Cancer Institute in 2008 found that there was no association between the risk of prostate cancer and any hormone measured, including testosterone, DHT, and estradiol. Gould et al.'s review of 15 studies of testosterone replacement, up to 15 years in duration, showed no increase of prostate cancer risk.78 Agarwal and Sarosdy found that testosterone treatment studies of patients with prostate cancer after radical prostatectomy and brachytherapy have shown no recurrences or significant increases of PSA.79,80 Morgantaler's study reported dramatic evidence on the safety profile of TRT: 13 testosterone-deficient men with biopsy-proven prostate cancer were treated with TRT.81 After 2.5 years, repeat biopsies were done and no cancer was found in 54%; there was also no local progression or metastasis found.
Attacks on Compounding Pharmacies
Compounding has been a foundational aspect of the practice of pharmacy. While today the majority of prescription medication is mass produced by pharmaceutical companies, many patients require custom-made preparations that are prescribed by their physician and compounded by a trained pharmacist.
Compounding pharmacies are strictly regulated by the respective state boards of pharmacy. Presently, US Senate Bill S.959 would transfer control of compounding pharmacies to the FDA. This legislation would give sole authority of the FDA to determine what medications could be used in the practice of compounding. Knowing its long-time antipathy to bioidentical hormones, you can rest assured that the FDA would inevitably ban compounded bioidentical hormones. This has been its plan since the late 1980s. A series of federal court cases has prevented this. Despite this pending legislation, courts have repeatedly upheld pharmacists' rights to compound, even with repeated attempts by the FDA to challenge the activity. In May 2006, a US District court judge ruled that the compounding of ingredients to create a customized medication in accordance with a valid prescription does not create a new drug subject to the FDA's approval process (see Medical Center Pharmacy et al. v. Gonzales et al.). Additionally, the US Supreme Court has held as unconstitutional the FDA's repeated attempts to regulate pharmacist compounding.
Attacks on Credentialed Physicians
The American Board of Anti-Aging & Regenerative Medicine (ABAARM) issues board certification to individuals with MD (doctor of medicine), DO (doctor of osteopathic medicine), DPM (doctor of podiatric medicine), and MBBS (bachelor of medicine/bachelor of science) degrees; the American Board of Anti-Aging Health Practitioners (ABAAHP) issues diplomate certification to doctors of chiropractic (DC), doctors of dentistry (DDS), naturopathic doctors (ND), registered pharmacists (RPh), scientists (PhD and similar), registered nurses, nurse practitioners, and physician assistants, and licensed acupuncturists (LAc).
Through ABAARM and ABAAHP, the A4M is one of approximately 270 specialist medical societies and medical boards, only 24 of which in total have been approved by the American Board of Medical Specialties (ABMS). A self-appointed organization, ABMS most recently approved a medical specialty – nuclear medicine – in 1985, 28 years ago as of this writing. In a field of over 270 specialist medical societies, ABMS approval is an arduous, time-intensive, and resource-depleting process. The A4M is one of nearly 250 societies that have yet to receive ABMS approval. Statements that anti-aging medicine is not yet an ABMS-recognized medical specialty mischaracterize the reality of gaining such approval and to infer – improperly – a lack of credibility on the part of A4M.
Currently, A4M's educational programming awards category 1 AMA/Physician's Recognition Award (PRA) physician credits, the highest level available for physicians and surgeons. The content of A4M's academic congresses are closely monitored and supervised by AMA-approved CME accreditation bodies. A4M's educational programming has consistently received the highest ratings and excellent reviews for the quality of medical educational content by peer-reviewed organizations. A4M's educational programming has received recognition and support of national governments and universities worldwide.
Hormone Replacement Therapy
History
Hormone replacement therapies with controlled substances such as testosterone and growth hormone have been used since many years. The first treatment of testosterone deficiency in adult men started around 1940; and, since then, for more than 40 years growth hormone has been administered to treat short-stature children; since 1985, with the safer, uncontaminated recombinant growth hormone, a product of biotechnology. In the latter 1980s, the first clinical trial of adults with GHD were published, and since the beginning of the 1990s, growth hormone treatment of adult patients started in private medical practice.
The concept of interventional endocrinology acknowledges the fact that not everyone experiences symptoms of deficiency – relative or absolute – at the same levels. Therefore, taking a comprehensive medical history and physical can act to substantiate the application of replacement/supplementation protocols, in accordance with accepted standards of care. Clear documentation in this regard helps support the physician's approach in treating the patient.
Safety and Efficacy
To date, no adverse effects of hormone replacement therapies administered to adults with diagnosed deficiency(ies) have been reported to the FDA's Adverse Event Reporting System (FAERS), the national database providing postmarketing safety surveillance for drug and therapeutic biologic products. Likewise, as of this writing, the US CDC's Medication Safety Program contains no reports of adverse effects relating to HRT.
HGH therapy has been in use for over 40 years in adults and children, with one of the best safety records in modern pharmacy and whose dose in adults is typically only 1/5 to 1/7 of the pediatric dose and under the strict supervision of an endocrinologist or anti-aging specialist.82 As of this writing, the US National Library of Medicine's PubMed database lists over 100,000 peer-reviewed citations on HGH therapy; not a single death or permanent life-threatening morbidity has been reported on its use in otherwise healthy AGHD patients.
The side effects of GH replacement therapy, if any, are usually minor and are reversible by decreasing the dose or in a few cases discontinuing the treatment. Significant side effects are rarely seen in clinical practice. Also, when the same total dose is divided daily over a week-long period (instead of administering 3 days a week), side effects are diminished or absent. If side effects do occur, it has been clinically demonstrated that they disappear with cessation of treatment.
The Clinical Anti-Aging Setting
Most traditional endocrinologists have had no intense training in treatment of testosterone and growth hormone deficiencies. They generally have excellent training in the treatment of diabetes, but lack of interest and expertise in how to treat testosterone and AGHD and some other hormone deficiencies that may accelerate aging.
Because of this lack of knowledge, many of them have rejected these treatments and confused them with the improper use at excessive doses by sports athletes searching to improve their performance. The A4M, its numerous worldwide affiliated scientific and medical societies, and befriended organizations do not approve the improper use of these substance in sports but do point to the right of all patients suffering from one of these deficiencies to get relief from their complaints by the adequate hormone treatment.
Critics of the anti-aging medical science do acknowledge 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, in A4M's view, misplaced.
The therapeutic value of HGH was validated by a study conducted in Stockholm, Sweden.83 Data concerning visits to the doctor, number of days in hospital, and amount of sick leave were obtained from patients included in KIMS (Pharmacia International Metabolic Database), a large pharmacoepidemiological survey of hypopituitary adults with GHD, for 6 months before GH treatment and for 6 to 12 months after the start of treatment. Assistance required with normal daily activities was recorded at baseline and after 12 months of GH therapy. Quality of life (QoL; assessed using a disease-specific questionnaire, QoL-Assessment of GHD in Adults) and satisfaction with physical activity during leisure time were also assessed. For the total group (n = 304), visits to the doctor, number of days in hospital, and amount of sick leave decreased significantly (p < 0.05) after 12 months of GH therapy. Patients also needed less assistance with daily activities, although this was significant (p < 0.01) only for the men. QoL improved after 12 months of GH treatment (p < 0.001), and both the amount of physical activity and the patients' satisfaction with their level of physical activity improved after 12 months (p < 0.001). In conclusion, GH replacement therapy, in previously untreated adults with GHD, produces significant decreases in the use of health-care resources, which are correlated with improvements in QoL.
Concluding Remarks
Repeatedly since the genesis of the anti-aging medical movement in 1991, the media have sought to demonize the use of hormone replacement therapies in healthy but deficient adults. Relying on partisan – and often misinformed – critics, the media fuel and encourage hysteria among the public, which thereby results in a climate of misguided federal and state actions that seek to restrict these safe, proven, life-enhancing therapies.
Attempts to criminalize the practice of medicine wherein variations to state–board favored traditional care threaten the continued advancement of innovative medicine. In these situations, there are no injured patients and no victims, yet criminal proceedings are waged against progressive health professionals. State officials abuse their authority in recasting minor administrative issues criminal acts; this is unjust and may be considered as criminal abuse of their publicly elected positions. Sensationalization by media confuses the public, with false allegations suggesting that HRT in clinically documented cases of adult deficiency syndromes equates to the abuse of performance-enhancing anabolic steroids.
The American Academy of Anti-Aging Medicine (A4M) is resolute in defending the rights of patients working in conjunction with their physicians in choosing any and all justifiable therapies, drugs, and interventions that can be shown to improve either the quality or duration of the human lifespan or the form and function of the individual's physiology in order to achieve greater vitality and health at every age. It is in fact the physician's duty to advocate for the patient's right to obtain the full lawful measure of scientific medical therapeutics necessary for optimum health and personal freedom of choice in health care.
The observation by George Orwell (1903–1950), in the prognostic classic novel 1984, that "War is peace. Freedom is slavery. Ignorance is strength" predicts that in a world where lies are supported by the establishment, to stand firm for truth is a dangerous and revolutionary action. Physicians of conscience and good will must unite to take back the future – or all freedoms, including freedom of choice in health care, will be lost forever.
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