Anti-Aging Therapeutics Volume XV

publisher.

Chapter 1

The Non-Science Witch Hunt Against Hormone Replacement Therapies for Deficiency Syndromes Must End: An A4M Position Paper on Physician-Prescribed HRT

A4M American Academy of Anti-Aging Medicine

Issue Date: 23 September 2013

View Online at:

http://www.worldhealth.net/pdf/A4M-2013-Position-Statement-HRT.pdf

Supplemental Resources

White Paper Guidance for Physicians on Hormone Replacement Therapy; A4M, May 2007; available at: http://www.worldhealth.net/white-papers-official-statements/

Is consensus in anti-aging medical intervention an elusive expectation or a realistic goal?; Archives of Gerontology & Geriatrics (Elsevier); 48(3):271-276; (May 2009); available at:

http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6T4H-4VT0GW8-1&_user=10&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=7c846ae92417c7b587d070eeb4f71149

INTRODUCTION

Unless we put medical freedom into the Constitution, the time will come when medicine will organize into an undercover dictatorship to restrict the art of healing to one class of Men and deny equal privileges to others; the Constitution of the Republic should make a Special privilege for medical freedoms as well as religious freedom.

-- Benjamin Rush (1745-1813), physician, writer, educator, humanitarian,

and Founding Father of the United States

Since the inception of the anti-aging medical movement in 1991, various establishment parties have ruthlessly leveraged their positions of power in academic, political, and regulatory arenas for the purpose of attempting to limit the use of hormone replacement therapies (HRT) in adults with documented clinical deficiencies. For over 15 years, a prolonged and calculated campaign of deceit, fraud, and suppression has threatened physician licensures and liberties to treat and prescribe life-improving therapies, leading potentially to the direct compromise of patients’ health and longevity. Dozens of physicians have been sanctioned and punished with loss of license and academic standing. This pernicious abuse of position and power is particularly prevalent with regard to RECENT challenges made against human growth hormone (HGH), testosterone (TRT), and DHEA replacement therapies that are trumpeted by the mainstream media. Biased reporters frequently – and inappropriately – demonize legitimate physicians and clinical compounding pharmacies who are reluctantly positioned on the frontline of a decades’ old agenda to limit freedom of choice and information, and the physician’s most essential responsibility to select the best course of therapy and medication for their patients.

This conflict is being played out of late in the arena of anti-aging medicine, a clinical specialty that has flourished in its twenty-two year long history, garnering the support of more than 100,000 physicians and scientists worldwide who practice or research life enhancing, life extending interventions today. Prof. Dr. Imre Zs.-Nagy, of the University of Debrecen Medical and Health Science Center (Hungary), and founder of the Archives of Gerontology and Geriatrics (published by Elsevier), observes¹ that: In my role as a basic and clinical scientist, I have had an opportunity to witness more than four decades of advances and declines in the arena of preventive medical care … there has been little else as dramatic, important, beneficial, and significant as the anti-aging medical movement.

Continual vigilance is necessary to countermand those whose financial and professional successes depend on repeated, calculated attempts to discredit the science and substance of anti-aging medicine.

Remarks² Tanjung Subrata, MD, of Udayana University School of Medicine (Indonesia):

Anyone who does not believe in evil is not paying attention to the recent affairs of the past twenty years. We are living in a time of unprecedented tribulation and changes at-large – and in healthcare, in particular. All that is necessary for evil to prevail is for men of good will to do nothing. In this modern age of zero tolerance for alternatives to establishment medicine, and the willingness of our governmental officials to resort to police state tactics to suppress innovative schools of thought, progress in medicine halts and dies.

A4M POSITION

The American Academy of Anti-Aging Medicine (A4M), its numerous worldwide affiliated scientific and medical societies, and befriended organizations, supports the judicious application of modern and advanced medical technologies to address the changes in chemical, hormonal, physical, and nutritional needs that occurs with aging. Such repletion includes the restoration of hormones to an optimal physiological state when deficiency is determined by objective assessment.

Hormone replacement therapy (HRT) is an essential and extensively documented protocol for clinical intervention in the disorders of aging. HRT maintains an unblemished safety and efficacy profile that has been documented by 20 years of clinical application. Yet, a perfect storm of misguided media combined with biased parties whose livelihoods hinge on disparaging the anti-aging medical movement has grossly compromised access to HRT, placing the lives of hundreds of thousands of patients worldwide in potential jeopardy.

Experienced anti-aging physicians have been prescribing HRT for more than 20 years. PubMed contains more than 20,000 peer-reviewed studies of HRT, of which a preponderance document the life-enhancing and/or life extending benefits of HRT in aging adults. See Appendix A Literature Review which presents a selection of such studies that represent the objective evidence that supports the A4M position.

THE ANTI-AGING MEDICAL MOVEMENT

The goal of anti-aging medicine is not to merely prolong the total years of an individual's life, but to ensure that those years are enjoyed in a productive and vital fashion. As established in 1991 by the physicians of the American Academy of Anti-Aging Medicine (A4M), the field of anti-aging medicine was established as a direct extension to the science of elite sports medicine of the 1980s. Just as sports medicine aims to keep the athlete’s body functioning at its optimum level, anti-aging medicine seeks to keep the human physiology performing at its peak. In other words, the similar principle, of extending and maximizing the healthy human lifespan, is at the core of both anti-aging medicine and sports medicine.

The Official Definition of Anti-Aging Medicine

The clinical specialty of anti-aging medicine was established in 1991 by the physicians of the A4M, and thus is defined as follows:

Anti-aging medicine is a clinical specialty is founded on the application of advanced scientific and medical technologies for the early detection, prevention, treatment, and reversal of age-related dysfunction, disorders, and diseases. It is a healthcare model promoting innovative science and research to prolong the healthy lifespan in humans. As such, anti-aging medicine is based on principles of sound and responsible medical care that are consistent with those applied in other preventive health specialties. The phrase anti-aging, as such, relates to the application of advanced biomedical technologies focused on the early detection, prevention, and treatment of aging-related disease.

The clinical specialty of anti-aging medicine utilizes diagnostic protocols that are supported by scientific evidence to arrive at an objective assessment upon which effective treatment is assigned. Physicians who dispense anti-aging medical care are concerned with the restoration of optimal functioning of the human body’s systems, organs, tissues, and cells.

Attempting to rebrand what it cannot deny, those in positions of power in academic, political, and regulatory arenas are Inventing new catch phrases including longevity medicine, successful aging, healthy aging, and the like, in an effort to dilute and absorb the A4M's original definition of anti-aging medicine. To implement this campaign, we suspect that these individuals have pejoratively solicited major media outlets to denigrate the A4M, its officers, and its members.

Anti-aging medicine is, in essence, a euphemism for early detection and advanced preventative medicine. It is a healthcare model that emphasizes personalized, patient-focused, high-quality metabolic-specific medical care.

Critics with A Dark Agenda (Political Elites)

Scientifically based and well documented in leading medical journals, anti-aging medicine is among the fastest growing medical specialties throughout the world. As an innovative model for advanced preventive healthcare that cannot be denied, individuals with their own political and financial agendas have disparaged anti-aging medicine in attempts to restore monopolistic control over the field of aging intervention. Critics of the science of anti-aging medicine most commonly hail from academia: as such, these naysayers many times have little or no medical training in aging intervention, and may be non-clinicians.

Perhaps the most inconceivable reality is that at the very highest levels of academia, government, and science, truth and objective scientific method are not at all sacred to the political elites. We in clinical medicine via our training, discipline, and conditioning naively believe and act in the public interest, for the good of our patients’ health, and by professional standards of medical ethics. The (elite) medical establishment operates contrary to this position, reports investigative reporter Tim Bolen (www.bolenreport.com), who for 30 years has amassed data and evidence exposing a calculated effort to deride innovative medical therapeutics. Mr. Bolen observes³ that:

Without a doubt, a stealthy control group – a cabal, if you will, in status-quo medicine exists. Approved by Big Pharma, parts of academia, and segments of the government, this group exerts its control in many different ways. I have uncovered information showing anonymous, and not-so-anonymous, funding of groups, loosely describing themselves as Quackbusters or Skeptics whose only purpose is to attack cutting-edge health care offerings. Those groups, in turn, train, and fund sub-groups. Data suggests that the Quackbusters or Skeptics" donated over $1 Million US to Wikipedia to purchase control over pages with medical content. More, the Skeptic training camps teach their recruits how to operate together to control that same Wikipedia and Search Engines. Further, these covert groups drive media on issues particularly pertaining to alternative healthcare, in an effort to limit coverage of innovative discoveries and to vilify therapies that are not part of AMA/FDA/Big Pharma establishment medicine healthcare.

There are TWO main skeptic organizations - the James Randi Educational Foundation (JREF) and the Center For Inquiry (CFI). Both are well funded from secret sources.

JREF reported, in 2010, a total income of $999,971.00 and a Total Asset claim of $1,736,101.

The Center For Inquiry, Inc (CFI), based in Amherst, New York shows on their Form 990 that they took in $5,242,304 in Total 2009 Income, and they had, that year, Total Assets of $3,017,144. Their Schedule B ANONYMOUS contributions totaled $2,318,652.

More, CFI claimed that they received, in 2009, in addition to their anonymous contributions, a so-called Management Fee Income of $2,458,156. What do you suppose they managed? And who paid them to manage it? Maybe they manage Wikipedia health care articles? How about Search Engine Optimization (SEO) bringing skeptic, including Stephen Barrett's (Quackwatch), articles to the first page of Google?

Much more - This cabal minimizes and delays innovative medical advancements by lodging anonymous complaints to state licensing boards against cutting-edge practitioners. Their insidious campaign also controls grant monies and research funding, somewhat silencing the voices of innovative medicine in favor of mainstream views. By leveraging control of the media in direct jeopardy of journalistic integrity, this control group seeks to suppress all in medicine that is not fully controlled by the establishment. To permit this level of manipulation and disinformation is wrong and ethically corrupt. The fate of a valuable avenue of medical innovation for the public interest – anti-aging medicine – stands at-risk."

A JAMA commentary⁴ purported to address the legality of Human Growth Hormone (HGH, GH) treatment by physicians for growth hormone deficient (GHD) patients. It is the view of A4M that the commentary contained a number of incorrect, misplaced references and studies, and multiple basic scientific errors, in what A4M views as an apparent attempt to damage the anti-aging medical profession and the physicians practicing solid, evidence-based medical healthcare focused on improving and maintaining patients' quality of life. It is A4M's further opinion that the authors selected self-serving studies, in which they failed to qualify the conclusions in an effort to bolster what A4M believes is a disinformation campaign. It is A4M's opinion, for example, that they incorrectly intermingled internet sales of homeopathic pseudo GH sprays, amino acids, and sports nutritional over the counter products in order to inflate their incorrect 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.

Misrepresentation in Competitive Sports

As an unfortunate consequence of media confusion and outright deception aiming to deliberately misrepresent anti-aging medical care, the reality of the clinical practice of hormone replacement therapy has become muddled. A recent Sports Illustrated article states⁵ that: In the sports world, the term ‘anti-aging’ has often come to signify therapy that uses hormones – usually testosterone and HGH – and … DHEA. This erroneous definition grossly misrepresents the legal and ethical physiological use of hormones and supplements as being synonymous with the inappropriate use of hormones for sports enhancement. The A4M is squarely opposed to this myopic interpretation of anti-aging and urges reference to the official definition of anti-aging medicine as presented above.

Any use of performance enhancing drugs or hormones banned from professional sports constitutes inappropriate misuse. It is a violation of the A4M Physician Member Code of Ethics to prescribe for the explicit purposes of performance enhancement. The A4M does not endorse or condone the use of any illicit substances for sports cheating. However, the A4M does support the continued availability of such substances to adult patients with objectively assessed hormone deficiencies. Such judicious use of HRT does not equate to a banned drug issue.

A4M’s physician co-founders Dr. Robert Goldman, MD, PhD, DO, FAASP, Chairman; and Dr. Ronald Klatz, MD, DO, President, are co-authors of Death In the Locker Room (1984), a first-ever expose of the illicit use of anabolic steroids in sports, and Grow Young with HGH (1997), a best-selling book that explored the clinical benefits of judicious and appropriate HGH therapy in deficient adults. Death in the Locker Room is widely regarded as the seminal text on the dangers of anabolic and performance enhancing substances in sports. Death in the Locker Room was the first book to alert the public and the medical community to such issues, and the book subsequently led directly to much of the drug testing, control, and educational programs now in-place across a number of professional sports and on the global level.

Statute⁶ 21 U.S.C. § 333(e), a provision of the Food, Drug, and Cosmetic Act (FDCA), states, 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. The 1988 law was written and passed regarding anabolic steroids. The legislative history of the statute 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 1988 Summer Olympics (at which, ironically, Canadian sprinter Ben Johnson's steroid positive ignited a global firestorm).

Dr. Goldman served as Special Adviser & Lecturer to the US Drug Enforcement Agency (DEA) Demand Reduction Education Programs nationally, as well as to the US Olympic Committee, spearheading the design of drug policy and testing procedures. In his activities with the DEA, Dr. Goldman was directly involved in an advisory capacity with the process that led to the creation of the Anabolic Steroid Control Act of 1990. The Anabolic Steroid Control Act was never intended to restrict practicing physicians involved in the clinical treatment of hormone deficiency syndromes, comments⁷ Dr. Goldman, who explains that: Rather, this law was specifically directed to prevent the trafficking of anabolic steroids to athletes.

The Anabolic Steroid Control Act of 1990 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.⁸,⁹ 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. In fact, HGH was inserted as an afterthought, with no penalties mentioned, as editorial comment; there was no intention to criminalize its judicious use in the clinical setting by trained physicians. The focus of lawmakers and Congress has always been to address non-medical use, i.e., improper use by competitive elite athletes, sports people and teenagers. It is A4M's view that the JAMA commentary⁴ fails to understand or appreciate such legislative history and legislative purpose. A4M is advised that one of the authors of the 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.¹⁰ This is a very odd and A4M believes, an incorrect 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 five years after the 1988 statute was enacted. The concept of HGH s an anti-aging drug did not exist until the problem of Rudman’s study.¹²

The Anabolic Steroid Control Act never intended to infringe upon physician freedoms to prescribe hormone therapy when clinically appropriate. It was specifically intended to prevent steroid trafficking in professional sports. Whereas education should have been a primary goal in implementing the Anabolic Steroid Control Act, instead an enforcement environment that granted limitless power unto itself was created. A multi-million dollar industry of drug testing was born and subsequently flourishes.

DISINFORMATION CAMPAIGN

History is replete with examples of medical pioneers whose innovations and foresight were trivialized, ignored, challenged, or violently opposed by the establishment, only to ultimately become accepted by society at-large. Leopold Auenbrugger was ridiculed for percussing and auscultating his patients' chests; Ignaz Semmelweiss' recommendation for doctors to wash their hands before each patient landed him in a mental asylum; and more recently, cardiologists denied Nathan Pritikin's program for dietary modification to modulate cardiovascular risk until after his death. Given time and objective, undeniable evidence, scientific truths are ultimately borne out. In the words of Dr. Augenbrugger, It has always been the fate of those who have illustrated the arts and sciences by their discoveries to be beset by envy, malice, hatred, destruction, and calumny.

Misguided Attacks on HRT

Statute⁶ 21 U.S.C. § 333(e), a provision of the Food, Drug, and Cosmetic Act (FDCA), supports the use of hormone replacement in mature, clinically GH-deficient adults as both treatment of a disease and a medically authorized use granted by the FDA. Any implication that the statute was intended to target medical hormone replacement by ethical doctors in the new and emerging field of anti-aging medicine is therefore incorrect and misleading.

To obfuscate the truth, critics of the anti-aging medical science offer deliberately misleading claims concerning HRT with the specific and ultimate goal to severely restrict the use of hormone therapy. Most notably, the JAMA commentary⁴ purported to address the legality of Human Growth Hormone (HGH, GH) treatment by physicians for growth hormone deficient (GHD) patients. The commentary, however, was flawed by a number of incorrect, misplaced references and studies, and multiple basic scientific errors.

In the May-June 2009 issue¹ of the prestigious Archives of Gerontology and Geriatrics, an international journal integrating experimental, clinical, and social studies on aging published by Elsevier, founder and Editor-in-Chief Prof. Dr. Imre Zs.-Nagy expresses his opinions on the use of the HGH as an anti-aging medical intervention. Prof. Dr. Nagy’s Editorial points out the main clinical results of HGH replacement therapy (hGHRT) in light of the Membrane Hypothesis of Aging (MHA), which he submits as offering a solid basis for the interpretation of the observed beneficial effects of HGH. Prof. Dr. Zs.-Nagy’s profile of the sharp and protracted conflict of views between the gerontological establishment and the A4M exposes a disregard by certain individuals bearing some of the most prestigious affiliations in the gerontological establishment, for truth, academic integrity, and scientific professionalism. Dr. Zs.-Nagy submits that: [T]he gerontological elite has … sought to obfuscate the facts of the anti-aging medical movement. I submit that the reason for this is nothing less than an abject fear by the gerontological elite to avert their loss of control, power, prestige, and position in the multi-billion dollar industry of gerontological medicine. ’

Elite athlete and professional sports/medical writer Monica Mollica observes¹¹ that: For reasons that are not readily apparent, there appears to be a conservative political movement that opposes the use of testosterone in older men. Continuing, Ms. Mollica observes that: The political climate is working against testosterone replacement therapy in older men despite overwhelming scientific data supporting this appropriate pursuit as a strategy to prolong healthy longevity."

`

HGH

On July 5, 1990, Daniel Rudman, M.D., a pioneer researcher in the use of HGH, and his colleagues at the Medical College of Wisconsin made medical history with an article¹² in the New England Journal of Medicine. It detailed the first clinical trial of elderly men on HGH therapy, which compared the effects of 6 months of HGH injections on 12 men, aged 61 to 81 years, with an age-matched control group. The result made headlines all over the world. Those taking the hormone injections gained an average of 8.8% in lean body mass and lost 14% fat, without diets or exercise. Their skin became thicker and firmer and the lumbar bones of the spine increased. In other words, HGH had virtually turned their flabby, frail, bodies into their sleeker, stronger, younger selves. In language rarely used in conservative medical journals, the researchers wrote: The effects of 6 months of HGH on lean body mass and adipose-tissue mass were equivalent in magnitude to the changes incurred during 10 to 20 years of aging.

HGH is one of the most studied compounds in medicine with almost 100,000 journal references currently in PubMed. The majority of these data demonstrate the positive benefits of HGH therapy in multi-year studies, well beyond the typical 6-12 month study protocols. ¹³,¹⁴

Growth hormone replacement therapy has been shown to improve muscle strength and mobility, cognitive function, cardiovascular disease, osteoporosis, immune function, body composition, obesity and sarcopenia, fibromyalgia, Crohn's disease, other illnesses, and quality of life issues.¹⁵,¹⁶,¹⁷,¹⁸,¹⁹,²⁰,²¹

Low GH²² is associated with decreased longevity in humans, with more than 20 years decreased lifespan with low GH.²³ Older men with higher IGF-1 do not show the same decrease in lean body mass and increase in fat mass. GH determines life’s potential.²⁴ Childhood or adult GH deficiency is associated with 2-3 times increase in mortality.²⁵

Low GH²² and its downstream hormone IGF-1 are associated with poor health and quality of life outcomes. The June 2012 issue²⁶ of The Journals of Gerontology: Series A published a series of articles documenting the clinical benefits of IGF-1. Of note, Higashi et al²⁷ provide a comprehensive update on IGF-1's ability to modulate vascular oxidative stress and to limit atherogenesis and the vascular complications of aging. Further, Ungvari et al²⁸ cite the cardiovascular protective effects of insulin-like growth factor (IGF)-1 [to] [provide] a landscape of molecular mechanisms involved in cardiovascular alterations in patients and animal models with … adult-onset IGF-1 deficiency, submitting that: Microvascular protection conferred by endocrine and paracrine IGF-1 signaling suggest its implications for the pathophysiology of cardiac failure and vascular cognitive impairment, and the role of impaired cellular stress resistance in cardiovascular aging.

The 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines reports²⁹ that treating GH deficiency in patients with chronic heart failure beneficially affects the primary endpoint of peak oxygen consumption, which showed remarkable increases of 7.1 ml/kg/m in GH-treated patients, as compared to a decrease of 1.8 ml/kg/m among control subjects. In that left ejection fraction rose by 10% in the GH-treated patients (declined 2% in controls); with a greater effect on left ventricular and systolic volume index of -22 ml/m2 (as compared to increase of 8 ml/m2 in controls), the American College of Cardiology Foundation/American Heart Association Task Force writes that: The improvements … are consolidated predictors of survival. Notably, there were no major adverse events among the GH-treated patients.

As stated by Savine: If mean IGF-1 of 300 is mean normal for 20-30 year olds, almost all men and women over the age of 40 have an IGF-1 deficit.³⁰ Most patients beyond age 60 have total 24 hour HGH secretion rates indistinguishable from those of hypopituitary patients with organic pituitary gland lesions.³⁰ Therefore the A4M submits that the empirical data suggests that when treating Adult Growth Hormone Deficiency (AGHD, GHD), physicians are treating a documented deficiency disease and not performing off-label treatment as the JAMA commentary⁴ authors suggest. In fact, HGH deficiency is associated with significantly decreased longevity in human siblings. Longevity and healthy aging are directly related to GH/IGF-1 levels.³¹ As Savine points out, Life without GH is poor in quantity and quality.³⁰

When AGHD is treated with GH, there are usually increases in GH, IGF-1 and IGF Binding Protein 3 (IGFBP-3) which all have a role in clinical results. Although IGF-1 is pro-mitotic and taken out of context could promote cancer, IGFBP-3 is anti cancer.³² The mechanism is explained by stimulation of anti-cancer gene p53. Teenagers with the highest GH and IGF-1 have low rates of cancer. When treating with GH a balance is produced between IGF-1 and IGFBP-3.³³ A central question in GHRT is Does GHRT increase the risk of cancer. Multiple studies and reviews have concluded that there is no increase in cancer risk compared to the general population. Jenkins³⁴ review is aptly titled, Does Growth Hormone cause cancer? and provides the conclusion:

"Extensive studies of the outcome of GH replacement in childhood cancer survivors show no evidence of an excess of de novo cancers, and more recent surveillance of children and

adults treated with GH has revealed no increase in observed cancer risk."

Moltich’s³⁵ review has similar conclusions:

Although there has been some concern about an increased risk of cancer, reviews of existing, well-maintained databases of treated patients have shown this theoretical risk to be nonexistent

With regard for the potential for an increased cancer risk with HGH treatment, peer-reviewed literature suggests the opposite. HGH treatment may up-regulate binding proteins of IGF, specifically IGF-6; this has been noted in studies to prevent many types of cancer, such as prostate, ovarian, brain and endometrial.³⁶,³⁷,³⁸,³⁹,⁴⁰,⁴² It is also well documented that cancer survivor children who received HGH did not exhibit any increased cancer risks. In fact, there are no peer reviewed long-term clinical studies that document human cancer risks from HGH administration.³⁸,³⁹,⁴⁰ To the contrary, cancer mortality and recurrence has been found to be reduced, or survival time increased in cancer patients on HGH. Patients deficient in HGH are reported to have a 400% increase in cancer mortality and a 200% increase of cancer incidence.⁴¹,⁴² Noted was also a reduction by 50% of cancer risk to patients with long term HGH replacement (60 months).²¹ Additionally, the Growth Hormone Research Society has stated that Current labeling for GH states that active malignancy is a contraindication. ... There are no data to support this labeling. Current knowledge does not warrant additional warning about cancer risk.⁴³ However, caution should always be exercised in patients with a history of cancer; and HGH therapy is not for every patient.

Ruiz-Torres et al²⁴ completed a study that compared ageing parameters of young (up to 39 years) and old (over 70 years) individuals having similar insulin-like growth factor-1 (IGF-1) blood levels. In follow-up, the researchers studied the decline in IGF-1 levels, comparing its behavior in the first half with that in the second half of adult life. The investigators concluded that: GH secretion in adulthood plays a determinant role not only for some regressive manifestations, but also for life potential.

Media reports about the federal law concerning HGH have created unnecessary confusion, and some reports have confused non-medical over-the-counter homeopathic sprays and nutritional products with pharmaceutical-grade, FDA-approved injection medications for AGHD patients. It is A4M's opinion that such misleading journalism incorrectly equates 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, in A4M's view, 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. It should be noted, that before initiating HGH supplementation, anti-aging physicians first encourage the increase of growth hormone by increasing exercise, enhancing sleep cycles, balancing other hormone deficiencies and decreasing of sugar intake, as evaluated by Gardner, et al.⁴⁴

In a landmark court case⁴⁵, James Forsythe, MD, HMD won a clear and unanimous victory that reaffirmed the right of a physician to prescribe HGH to adults with deficiency conditions, including aging and arthritis. Dr. Forsythe comments⁴⁶ that: "It is a perversion of the law for state licensing boards to mistreat and harass physicians for this legal, just, and appropriate use of this lifesaving medication – human growth hormone."

DHEA

Dehydroepiandrosterone (DHEA) is the most abundant steroid in the human body and is involved in the manufacture of testosterone, estrogen, progesterone, and corticosterone.

There is evidence to suggest that DHEA may stimulate human growth hormone (HGH). Morales et al⁴⁷ published results of a double blind, placebo-controlled, crossover study involving 71 women and 13 men, ages of 40 to 70 years. Subjects took 50 mg of DHEA for three months, followed by a placebo for three months. While subjects were receiving DHEA, their levels of DHEA and DHEA-S rose to that of a young adult within 2 weeks of DHEA replacement and were sustained throughout the 3 months of the study. Furthermore 84% of women and 67% of men reported an improved sense of both physical and psychological well-being, including improved sleep quality, increased energy levels, improved ability to handle stress, and increased sense of relaxation. Five of the volunteers also noted improvement in chronic joint pain and mobility. The researchers also found that DHEA caused a significant rise in IGF-1 levels, although it did not affect the 24-hour measurement of HGH levels. They speculate that restoring the levels of DHEA may stimulate the liver to produce more IGF-1 or generate more HGH receptors. In other words, we may find that the anti-aging benefits attributed to DHEA may actually be due to the stimulation of the HGH-IGF-1 system.

When²² DHEA levels are in an optimal range, there can be less risk of developing atherosclerosis. Rabijewski⁴⁸ found that DHEA could lower insulin levels and decrease the risk for developing type II diabetes. DHEA also decreases the risk of cancer because it enhances the immune system response. DHEA is also thought to be neuroprotective.

Prof. Etienne-Emile Baulieu, world known researcher and endocrinologists at INSERM in Paris, former president of the French Academy of science,Honorary member of College of France, known for his work on contraception and on steroid hormones was the first to synthesize DHEA in the sixties. Prof. Baulieu conducted numerous conclusive researches on the efficiency and benefits of DHEA. His findings underline the systematic positive results of administrating DHEA in his experimental and clinical studies, especially in men. His findings demonstrate that 50 mg of DHEA in 280 participants during a year had significantly improved their bone mass, skin thickness and pigmentation, as well as the libido in both men and women, the general physical and mental well-being were improved too.⁴⁹,⁵⁰ In an interview for a study on anti-aging medicine, Prof. Baulieu declares: One of the most important effects of DHEA has not yet received enough attention: it acts on the receptors of neurotransmitters. There are very encourageing research on the well being and improvement of memory in old age⁵¹

Testosterone

Testosterone is the main hormone produced in the testicles and secreted by the testes. Testosterone deficiency has pleiotropic deleterious effects. There is increased cardiovascular system dysfunction, which can lead to the increased incidence of AMI’s and strokes. Citing separately published data finding that: "serum testosterone levels were proved to be an independent negative predictor for developing arterial stiffness, assessed from the peak

systolic and end diastolic diameters of the common carotid artery and simultaneous brachial artery blood pressure, Kelly and Jones⁶² submit that: testosterone has demonstrated anti-inflammatory effects clinically and [testosterone replacement therapy] can improve atherosclerosis assessed non-invasively in hypogonadal men and in animal studies."

Testosterone²² optimization is anti-inflammatory. Testosterone prevents cytokine production and initiates the acute phase response, which elevates C-reactive protein, serum amyloid A and fibrinogen. Testosterone also prevents the formation of the adhesion molecules vascular cell adhesive molecule (VCAM) and intercellular adhesive molecule, (CD 54/ICAM), which are necessary components of the process of atherosclerosis. Thus, testosterone replacement is a very powerful anti-inflammatory treatment that can help to prevent atherosclerosis. Testosterone has also been shown to be of benefit in thetreatment of chronic heart failure. Pugh et al.⁵³ found that testosterone increases cardiac output, decreases left ventricular load, and has no adverse cardiovascular effects. Malkin et al.⁵⁴ show that testosterone replacement moderates inflammatory cytokines and improves heart failure outcomes. Turhan et al.⁵⁵ found that men with low free testosterone levels have greater than 3 times the risk for the development of coronary artery disease.

There²² is a common misconception that testosterone has adverse cardiovascular effects. However, the opposite has been shown with current research. The lower the free testosterone level the more likely coronary artery disease will be present. Testosterone replacement therapy (TRT) improves ST depression and dilates coronary arteries. TRT also may improve lipids and low testosterone is associated with dyslipidemia. English et al. found that low-dose transdermal testosterone therapy improves angina threshold in men with chronic stable angina. Rosano et al.⁵⁶ found that Short-term administration of testosterone induces a beneficial effect on exercise-induced myocardial ischemia in men with coronary artery disease. The same researchers also concluded that intracoronary testosterone has direct dilating effects on the coronary arteries. Finally, Hak et al.⁵⁷ found that low levels of endogenous androgens increase the risk of atherosclerosis in elderly men.

Testosterone²² can be a very powerful tool for the control of insulin resistance. Replacement doses decrease insulin resistance. Low levels of testosterone play a role in the development of type 2 diabetes. Low testosterone is associated with metabolic syndrome, hypertension, type II diabetes, fibromyalgia, and coronary artery disease. Boyanov et