Compounding by pharmacists 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 the respective state boards of pharmacy. Presently, U.S. Senate Bill S.959 would transfer control of compounding pharmacies to the Food and Drug Administration (FDA). This legislation would give sole authority of the FDA to determine what medications could be used in the practice of compounding pharmacy. Knowing its long time antipathy to bio-identical hormones, you can rest assured that the FDA would inevitably ban compounded bio-identical 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 despite repeated attempts by the FDA to challenge the activity. In May 2006, a U.S. 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 U.S. Supreme Court has held as unconstitutional 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 M.D. (Doctor of Medicine), D.O. (Doctor of Osteopathic Medicine), Doctors of Podiatric Medicine (DPM), and M.B.B.S. (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 (L.Ac.).
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 (the “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 testosterone 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 and since 1985 with the safer, not contaminated recombinant growth hormone, product of biotechnology. In the latter 1980’s, the first clinical trial of adults with growth hormone deficiency 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 & Efficacy
To-date, no adverse effects of hormone replacement therapies administered to adults with diagnosed deficiency(ies) have been reported to the US FDA’s Adverse Event Reporting System (FAERS), the national database providing post-marketing 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 on adults and children82, with one of the best safety records in modern pharmacia 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. 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 in its use of AGHD in otherwise healthy but 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 adult growth hormone deficiencies 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 every patient who is 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 study83 conducted in Stockholm, Sweden. 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 6-12 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